pulse-biosciences

<div class="content-intro">Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients.&nbsp; The Company’s proprietary CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.
The Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit&nbsp;<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fpulsebiosciences.com%2F&amp;esheet=53299490&amp;newsitemid=20230202005390&amp;lan=en-US&amp;anchor=pulsebiosciences.com&amp;index=2&amp;md5=be5397cf42a2c83df28cd007fa26f3d9">pulsebiosciences.com</a> to learn more.
Why Join Us?
At Pulse Biosciences, we are driven by purpose and innovation.
<ul>
<li>Our Mission: To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients. To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards.&nbsp; We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.&nbsp;</li>
<li>Our Culture: A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration.</li>
<li>Our Commitment: Hiring the best and brightest minds to advance our world-class organization.</li>
</ul>
What You Will Experience:&nbsp; 
<ul>
<li>Culture and Purpose - Purposeful and rewarding work collaborating with bright and curious minds brings us together!</li>
<li>Innovative Environment - An environment that fosters innovation to take products from concept to human use quickly!</li>
<li>Growth Opportunities - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!</li>
<li>Comprehensive Benefits - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.</li>
<li>Ownership and Rewards&nbsp;- Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.</li>
<li>Work-Life Balance -&nbsp;Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.</li>
<li>Diversity &amp; Inclusion - A commitment to providing a respectful work environment to our diverse workforce.&nbsp;</li>
</ul></div>Pulse Biosciences is always looking for great talent. Although we do not have a current opening that matches your experience, we welcome you to submit your resume for future opportunities.&nbsp;
Thank you in advance for your interest.<div class="content-conclusion">Ready to Shape the Future of Healthcare?
Apply today to join Pulse Biosciences and help us redefine the boundaries of medicine with bioelectric innovation.&nbsp; To learn more about us, visit our website at <a href="http://www.pulsebiosciences.com">www.pulsebiosciences.com</a>.
We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.
PRINCIPALS ONLY; UNSOLICITED CANDIDATE SUBMISSIONS FROM RECRUITERS OR THIRD-PARTY AGENCIES WILL BE CONSIDERED FREE REFERRALS.</div>

GENERAL JOB APPLICATION

<div class="content-intro">Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients.&nbsp; The Company’s proprietary CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.
The Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit&nbsp;<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fpulsebiosciences.com%2F&amp;esheet=53299490&amp;newsitemid=20230202005390&amp;lan=en-US&amp;anchor=pulsebiosciences.com&amp;index=2&amp;md5=be5397cf42a2c83df28cd007fa26f3d9">pulsebiosciences.com</a> to learn more.
Why Join Us?
At Pulse Biosciences, we are driven by purpose and innovation.
<ul>
<li>Our Mission: To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients. To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards.&nbsp; We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.&nbsp;</li>
<li>Our Culture: A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration.</li>
<li>Our Commitment: Hiring the best and brightest minds to advance our world-class organization.</li>
</ul>
What You Will Experience:&nbsp; 
<ul>
<li>Culture and Purpose - Purposeful and rewarding work collaborating with bright and curious minds brings us together!</li>
<li>Innovative Environment - An environment that fosters innovation to take products from concept to human use quickly!</li>
<li>Growth Opportunities - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!</li>
<li>Comprehensive Benefits - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.</li>
<li>Ownership and Rewards&nbsp;- Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.</li>
<li>Work-Life Balance -&nbsp;Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.</li>
<li>Diversity &amp; Inclusion - A commitment to providing a respectful work environment to our diverse workforce.&nbsp;</li>
</ul></div>About the Role
The Principal Software Quality Engineer will be responsible for quality assurance activities related to software/system development, verification, validation, and overall system functionality and reliability of the CellFX system and accessories in support of the Company’s research and development, manufacturing, regulatory, clinical investigations, and commercial efforts.&nbsp; In addition, this position will support the development and implementation of quality systems and regulatory filing activities.
To Make an Impact, You Will:
<ul>
<li>Provide expertise and guidance to product development and manufacturing teams in the areas of SW quality assurance, design controls and compliance.</li>
<li>Develop, establish and maintain SW quality engineering methodologies, systems and practices that meet Pulse Biosciences’ customer and regulatory requirements.</li>
<li>Proactively investigate, identify and implement best-in-class SW quality engineering practices.</li>
<li>Identify and implement effective process control systems to support the development, qualification and on-going manufacturing of products to meet or exceed internal and external requirements.</li>
<li>Develop and validate SW methods, monitor medical device SW standards, facilitate and perform SW code review.</li>
<li>Assist with preparation of regulatory submissions, regulatory assessments related to software changes and cybersecurity.</li>
<li>Development of SW standard operating procedures, SW test methodologies, and software verification &amp; validation protocols and reports.</li>
<li>Design and implement methods and procedures for SW release, SW field upgrade, and final quality assurance.&nbsp;</li>
<li>Work closely with the Software Development Team to plan, schedule, and improve development test processes.</li>
<li>Work well in a collaborative team environment with other engineers, developers and end users with minimal supervision and ensure understanding and validation of business requirements.</li>
<li>Perform validation and verification testing of medical devices and equipment in an FDA regulated environment.</li>
<li>Support internal quality audits, management review activities, Notified Body audits (ISO), and FDA QSIT audits.</li>
<li>Assist with development of product labeling, translation, and investigator brochures for commercial and clinical studies.</li>
<li>Supervise employees as assigned.</li>
<li>Carry out responsibilities in accordance with the organization’s policies and applicable laws.</li>
<li>Support the Pulse Biosciences Quality Policy and Quality System.</li>
</ul>
To Excel, You Will Bring:
<ul>
<li>Bachelor’s degree in Computer Science, Software Engineering, Computer Engineering or related field.</li>
<li>10+ years hands-on working experience in the field of SW quality assurance, SW testing, and/or SW development with at least 5+ years working with complex energy-based medical device system and Class III devices with SW. Cardiovascular devices are preferred.</li>
<li>Familiarity with the use of quality disciplines, tools, and methodologies</li>
<li>Working experience with various FDA software validation and Cybersecurity guidance’s and IEC 62304 Software Lifecycle process standard requirements</li>
<li>Must have working knowledge and experience in the following areas: Design Control, Design &amp; Process Validation, Risk Management, Cybersecurity, Quality system compliance, Complaint handling, MDR/Vigilance Reporting, and CAPA program.&nbsp;</li>
<li>ANSI/AAMI/IEC 62304:2006 Medical device software –Software life cycle processes</li>
<li>Medical Electrical Safety and EMC standards (IEC 60601-1, IEC 60601-1-2) and Risk Assessment (ISO 14971: 2019) including Cybersecurity practices and implementation.</li>
<li>The ideal candidate will have background in software test development, test methodologies and test automation for native applications built QNX or Similar OS.</li>
<li>Good communication skills, including experience writing technical documentation, test protocol, test reports, etc.</li>
<li>Must have excellent oral and written communication and project management skills</li>
<li>Proven ability to independently manage critical projects as part of an interdisciplinary team and navigate challenges to deadlines.</li>
<li>Hands-on experience preparing, managing and submitting major regulatory submissions.</li>
<li>Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.</li>
<li>Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast-growing company.</li>
<li>Proficient knowledge and skill in Microsoft Office Suite applications.</li>
<li>Ability to travel up to 10% of the time. Overnight and/or international travel may be required.</li>
<li>Ability to lift 10-15 pounds.</li>
</ul>
Pay Range:
Compensation is determined based on a wide range of factors including location, job-related skills, experience, education, and training. It is not typical for an individual to be hired at or near the top of the range for their role. This pay range is specific to Northern California location. Base salary range: $165k-$200k. This position is located onsite in Hayward, CA and candidates must reside in the San Francisco Bay Area. No relocation offered.<div class="content-conclusion">Ready to Shape the Future of Healthcare?
Apply today to join Pulse Biosciences and help us redefine the boundaries of medicine with bioelectric innovation.&nbsp; To learn more about us, visit our website at <a href="http://www.pulsebiosciences.com">www.pulsebiosciences.com</a>.
We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.
PRINCIPALS ONLY; UNSOLICITED CANDIDATE SUBMISSIONS FROM RECRUITERS OR THIRD-PARTY AGENCIES WILL BE CONSIDERED FREE REFERRALS.</div>

Principal Software Quality Engineer

<div class="content-intro">Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients.&nbsp; The Company’s proprietary CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.
The Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit&nbsp;<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fpulsebiosciences.com%2F&amp;esheet=53299490&amp;newsitemid=20230202005390&amp;lan=en-US&amp;anchor=pulsebiosciences.com&amp;index=2&amp;md5=be5397cf42a2c83df28cd007fa26f3d9">pulsebiosciences.com</a> to learn more.
Why Join Us?
At Pulse Biosciences, we are driven by purpose and innovation.
<ul>
<li>Our Mission: To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients. To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards.&nbsp; We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.&nbsp;</li>
<li>Our Culture: A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration.</li>
<li>Our Commitment: Hiring the best and brightest minds to advance our world-class organization.</li>
</ul>
What You Will Experience:&nbsp; 
<ul>
<li>Culture and Purpose - Purposeful and rewarding work collaborating with bright and curious minds brings us together!</li>
<li>Innovative Environment - An environment that fosters innovation to take products from concept to human use quickly!</li>
<li>Growth Opportunities - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!</li>
<li>Comprehensive Benefits - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.</li>
<li>Ownership and Rewards&nbsp;- Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.</li>
<li>Work-Life Balance -&nbsp;Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.</li>
<li>Diversity &amp; Inclusion - A commitment to providing a respectful work environment to our diverse workforce.&nbsp;</li>
</ul></div>About the Role
The Principal Quality Engineer will participate in the implementation and maintenance of QSR (21 CFR 820) and ISO 13485 quality systems and qualification activities of CellFX System, surgical disposable and reusable medical devices in support of the Company’s research and development, manufacturing, regulatory, and clinical affairs efforts.&nbsp; In addition, this individual will support the development and implementation of quality systems and compliance activities.
To Make an Impact, You Will:
<ul>
<li>Provide expertise and guidance to product development and manufacturing teams in the areas of design assurance, design controls and compliance.</li>
<li>Develop, establish, and maintain quality engineering methodologies, systems and practices that meet Pulse Biosciences’ customer and regulatory requirements.</li>
<li>Lead the risk management process in establishing risk management plan, conducting risk evaluation and analysis, and creating risk management report.</li>
<li>Lead the process in establishing product traceability matrices, conducting requirement trace verification and analysis, and creating trace matrix reports.</li>
<li>Manage all aspects of biocompatibility testing and sterilization including creating of test protocols and executing of testing.</li>
<li>Proactively investigate, identify, and implement best-in-class quality engineering practices.</li>
<li>Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.</li>
<li>Develop and validate measurement methods, monitor design control standards, facilitate, and perform statistical analysis, and participate in MRB as appropriate.</li>
<li>Lead the review of process and product quality performance, working in concert with various departments.</li>
<li>Assist with development protocols for design verification and validation in conjunction with R&amp;D</li>
<li>Design and implement methods and procedures for inspecting, testing, and evaluating components, sub-assemblies, and final assemblies.</li>
<li>Support management review activities, regulatory audits including Notified Body audit (MDSAP) and assist with preparation of regulatory submissions.</li>
<li>Carry out responsibilities in accordance with the organization’s policies and applicable laws.</li>
<li>Support the Pulse Biosciences Quality Policy and Quality System. Other duties as assigned.</li>
</ul>
To Excel, You Will Bring:
<ul>
<li>Bachelor’s degree in Engineering, Science, related technical/life science field or equivalent experience.</li>
<li>10+ years working as a Quality Engineer within a Class III/II medical device industry. Cardiovascular device experience is preferred.</li>
<li>Must have extensive work experience with FDA QSR (21 CFR Part 820 &amp; Part 11) and ISO 13485/MDR requirements are required.</li>
<li>Must have extensive knowledge and experience in Risk Assessment (ISO 14971) practices and implementation.</li>
<li>Knowledge and experience in ISO 10993 standard series (Biocompatibility), AAMI/ISO 11135 &amp; 11137 (EO &amp; Irradiation sterilization), ISO 11607 &amp; ASTM D4169 (Sterile Packaging &amp; Performance Testing).</li>
<li>Hands-on experience with catheter-based devices from development through commercialization.</li>
<li>Mastered the use of quality disciplines, tools, and methodologies.</li>
<li>Must also have working knowledge and experience in the following areas:
<ul>
<li>Design Control</li>
<li>Design &amp; Process Validation</li>
<li>Risk Management</li>
<li>Traceability Matrix</li>
<li>Biocompatibility</li>
<li>Sterilization Validation</li>
<li>Packaging Validation</li>
<li>Statistical Analysis</li>
<li>Quality System Compliance</li>
<li>Complaint handling</li>
<li>CAPA management</li>
</ul>
</li>
<li>Proficient knowledge and skill in Microsoft Office Suite applications.</li>
<li>Excellent oral written communication skills and critical thinking skills.</li>
<li>Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.</li>
<li>Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast-growing company.</li>
<li>Ability to travel up to 10% of the time. Overnight and/or international travel may be required.</li>
<li>Ability to lift 10-15 pounds.</li>
</ul>
Pay Range:
Compensation is determined based on a wide range of factors including location, job-related skills, experience, education, and training. It is not typical for an individual to be hired at or near the top of the range for their role. This pay range is specific to Northern California location. Base salary range: $145k-$180k. This position is located onsite in Hayward, CA and candidates must reside in the San Francisco Bay Area. No relocation offered.<div class="content-conclusion">Ready to Shape the Future of Healthcare?
Apply today to join Pulse Biosciences and help us redefine the boundaries of medicine with bioelectric innovation.&nbsp; To learn more about us, visit our website at <a href="http://www.pulsebiosciences.com">www.pulsebiosciences.com</a>.
We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.
PRINCIPALS ONLY; UNSOLICITED CANDIDATE SUBMISSIONS FROM RECRUITERS OR THIRD-PARTY AGENCIES WILL BE CONSIDERED FREE REFERRALS.</div>

Principal Quality Engineer

<div class="content-intro">Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients.&nbsp; The Company’s proprietary CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.
The Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit&nbsp;<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fpulsebiosciences.com%2F&amp;esheet=53299490&amp;newsitemid=20230202005390&amp;lan=en-US&amp;anchor=pulsebiosciences.com&amp;index=2&amp;md5=be5397cf42a2c83df28cd007fa26f3d9">pulsebiosciences.com</a> to learn more.
Why Join Us?
At Pulse Biosciences, we are driven by purpose and innovation.
<ul>
<li>Our Mission: To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients. To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards.&nbsp; We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.&nbsp;</li>
<li>Our Culture: A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration.</li>
<li>Our Commitment: Hiring the best and brightest minds to advance our world-class organization.</li>
</ul>
What You Will Experience:&nbsp; 
<ul>
<li>Culture and Purpose - Purposeful and rewarding work collaborating with bright and curious minds brings us together!</li>
<li>Innovative Environment - An environment that fosters innovation to take products from concept to human use quickly!</li>
<li>Growth Opportunities - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!</li>
<li>Comprehensive Benefits - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.</li>
<li>Ownership and Rewards&nbsp;- Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.</li>
<li>Work-Life Balance -&nbsp;Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.</li>
<li>Diversity &amp; Inclusion - A commitment to providing a respectful work environment to our diverse workforce.&nbsp;</li>
</ul></div>About the Role
The Principal Global Regulatory Affairs Specialist will be responsible for regulatory activities related to the development and implementation of global regulatory strategies to support the submission, filing, and registration of multiple indications (clinical applications or “apps”) in general surgery, and cardiac surgery and dermatology medical devices in targeted global markets. She/he provides leadership in the strategic guidance and execution of regulatory concepts within cross-functional project teams and supports interactions with global health authorities and corporate partners with regulatory deliverables. &nbsp;She/he brings direct and hands on experience supporting the development and implementation of FDA QSR, EU MDR (EU 2017/745) and ISO 13485: 2016 QMS, and applicable international regulatory compliance activities.
To Make an Impact, You Will:
<ul>
<li>Implement competitive and effective global regulatory strategies for various general surgery, cardiac surgery, and dermatology products including clinical/NSR and identify potential risks associated with proposed strategies.</li>
<li>Manage and drive all aspects of international regulatory affairs from creation to submission of technical documentation such as Technical Files, Design Dossiers including the General Safety and Performance Requirements (GSPRs) for product CE Marking and post-market follow-ups, amendments/supplements related to clinical trials under the new EU MDR (EU 2017/745).</li>
<li>Support FDA regulatory with the creation, review, editing, assembly and submission of domestic FDA regulatory documentation such as 510ks, Pre-subs, Letter-to-Files, IDEs, PMAs, etc. including regulatory responses and agency interactions.</li>
<li>Oversee the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.</li>
<li>Interact with regulatory agencies to expedite submissions, and/or approval of pending registrations.</li>
<li>Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management.</li>
<li>Collaborate with clinical operations to ensure clinical study results and reports are suitable for regulatory submissions.</li>
<li>Responsible for adverse event (Vigilance, MDR) reporting and assessments of AE’s to determine “reportable” events. Provide regulatory support as required in the evaluation of product complaints and ensuring AE reports meet regulatory requirements.</li>
<li>Establish and maintain procedures relating to the MDR/CE Marking processes in accordance with MDCG, ISO, and applicable international and country-specific regulatory requirements.</li>
<li>Serve as regulatory liaison throughout product development lifecycle.</li>
<li>Participate in some of the following: product plan development and implementation, regulatory strategy, product labeling, risk management, post-market surveillance and post-market follow-up.</li>
<li>Ensure alignment of regulatory strategy to business strategy across all functional areas including timely approval of new medical devices and continued expansion approvals of marketed products.</li>
<li>Serve as regulatory representative to marketing, clinical, research teams and regulatory agencies.</li>
<li>Ensure regulatory submissions and technical documentation meet appropriate standards, guidance, and content requirements.</li>
<li>Advise development and/or marketing teams on product changes, line extensions, technical labeling, appropriate regulations and interpretations.</li>
<li>Write regulatory justifications to support design changes and submission filing decisions.</li>
<li>Carry out responsibilities in accordance with the organization’s policies and applicable laws.</li>
<li>Support the Pulse Biosciences Quality Policy and Quality System.</li>
</ul>
To Excel, You Will Bring:
<ul>
<li>Bachelor’s degree in Engineering, technical related discipline, other life science related discipline or equivalent experience.</li>
<li>10+ years of experience in Global Regulatory Affairs in the medical device or biotechnology industries, including an in-depth knowledge and understanding of the regulatory environment or 8+ years of experience with a Master’s degree.</li>
<li>Experience creating PMA submission and CE Marking under MDR required</li>
<li>Regulatory experience in general/plastics surgery, cardiology, and/or dermatology (aesthetics) highly preferred.</li>
<li>Experience with Notified Body, Authorized Representative, Competent Authority and regulatory intelligence activities and clinical registration databases to support product approval strategies.</li>
<li>Knowledge of current EU regulations, Notified Body conformity assessment including experience preparing, compiling, filing, and performing life-cycle management of applications and all Technical Documentation format.</li>
<li>Experience with health authority meeting preparation.</li>
<li>Experience with Class III devices.</li>
<li>Solid understanding of both EU MDR 2017/745, ISO 13485: 2016 and FDA QSMR regulations.</li>
<li>Proven ability to independently manage critical projects as part of an interdisciplinary team and navigate challenges to deadlines.</li>
<li>Hands-on experience preparing, managing and submitting major regulatory submissions.</li>
<li>Excellent oral and written communication skills with critical thinking skills.</li>
<li>Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.</li>
<li>Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast-growing company.</li>
<li>Proficient knowledge and skill in Microsoft Office Suite applications.</li>
<li>Ability to travel up to 10% of the time. Overnight and/or international travel may be required.</li>
<li>Ability to lift 10-15 pounds.</li>
</ul>
Pay Range:
Compensation is determined based on a wide range of factors including location, job-related skills, experience, education, and training. It is not typical for an individual to be hired at or near the top of the range for their role. This pay range is specific to Northern California location. Base salary range: $160k-$190k. This position is located onsite in Hayward, CA and candidates must reside in the San Francisco Bay Area. No relocation offered.<div class="content-conclusion">Ready to Shape the Future of Healthcare?
Apply today to join Pulse Biosciences and help us redefine the boundaries of medicine with bioelectric innovation.&nbsp; To learn more about us, visit our website at <a href="http://www.pulsebiosciences.com">www.pulsebiosciences.com</a>.
We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.
PRINCIPALS ONLY; UNSOLICITED CANDIDATE SUBMISSIONS FROM RECRUITERS OR THIRD-PARTY AGENCIES WILL BE CONSIDERED FREE REFERRALS.</div>

Principal Global Regulatory Affairs Specialist

<div class="content-intro">Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients.&nbsp; The Company’s proprietary CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.
The Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit&nbsp;<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fpulsebiosciences.com%2F&amp;esheet=53299490&amp;newsitemid=20230202005390&amp;lan=en-US&amp;anchor=pulsebiosciences.com&amp;index=2&amp;md5=be5397cf42a2c83df28cd007fa26f3d9">pulsebiosciences.com</a> to learn more.
Why Join Us?
At Pulse Biosciences, we are driven by purpose and innovation.
<ul>
<li>Our Mission: To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients. To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards.&nbsp; We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.&nbsp;</li>
<li>Our Culture: A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration.</li>
<li>Our Commitment: Hiring the best and brightest minds to advance our world-class organization.</li>
</ul>
What You Will Experience:&nbsp; 
<ul>
<li>Culture and Purpose - Purposeful and rewarding work collaborating with bright and curious minds brings us together!</li>
<li>Innovative Environment - An environment that fosters innovation to take products from concept to human use quickly!</li>
<li>Growth Opportunities - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!</li>
<li>Comprehensive Benefits - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.</li>
<li>Ownership and Rewards&nbsp;- Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.</li>
<li>Work-Life Balance -&nbsp;Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.</li>
<li>Diversity &amp; Inclusion - A commitment to providing a respectful work environment to our diverse workforce.&nbsp;</li>
</ul></div>About the Role
The Senior Systems Administrator is a member of the IT infrastructure team and will assist with the planning, maintenance, operation, implementation and support of IT related products and services. The incumbent will manage priority projects and support our growing corporate infrastructure with day-to-day tasks and technical support. These projects and support emphasize security products but also include domain, server, network, cloud infrastructure support. This will include a broad spectrum of technology including Windows PCs/servers, LAN/WAN, Active Directory, network hardware, Email, backups VoIP systems, printers, and other SaaS systems and more. This is a dynamic role as it involves a mixture of skills for desktop support, server administration and project execution.
To Make an Impact, You Will:
<ul>
<li>Respond to help desk requests and troubleshooting end-user issues providing solutions via ticketing system, phone, and in person. Identify root-cause of systemic problems and escalate to the correct resource.</li>
<li>Manage Microsoft Windows operating systems, network infrastructure, firewall &amp; switches, troubleshooting server-based hardware, OS and software problems, and manage Active Directory.</li>
<li>Perform regular security monitoring to identify any possible intrusions as well as ongoing efficacy assessment of security policies and systems; review, recommend, and implement security systems and tools.</li>
<li>Investigate and troubleshoot infrastructure and systems with all levels of complexity issues across all platform and application domains in timely manner. Serve as a key stakeholder in all infrastructure and systems related incident response, and correction efforts. Coordinate and communicate with impacted parties.</li>
<li>Configure and administer backup, snapshots, data recovery, cloud storage and disaster recovery infrastructure. Verify network connectivity, document any issues or concerns as identified.</li>
<li>Administer IT servers and technology tools including troubleshooting, installations, configurations, upgrades, user administration, and server/network security.</li>
<li>Build, install, configure, analyze, tune, and troubleshoot server operating system, VMware, and firewall to achieve optimum performance levels.</li>
<li>Proactive in monitoring network performance with alerting mechanisms to ensure uptime availability and reliable data flow.</li>
<li>Compare, evaluate, and implement new technologies, and integrate systems into the computing environment.</li>
<li>Monitor, troubleshoot and support LAN/WAN and wireless infrastructure to ensure reliable, secure, and efficient day-to-day network operations.</li>
<li>Develop and document standards, policies, and procedures for specific IT environments along with system specifications, system design documentation, implementation processes, and operational support documentation.</li>
<li>Plan, organize, and coordinate all end-user trainings.</li>
<li>May perform other duties as assigned.</li>
</ul>
To Excel, You Will Bring:
<ul>
<li>Bachelor of Science degree in Computer Science, Information Technology Degree or equivalent experience.</li>
<li>5+ years of experience in systems administration and helpdesk support.</li>
<li>3+ years of experience with Palo Alto firewall and OKTA.</li>
<li>Strong working knowledge of Windows 11, Active Directory, Group Policy, Office 365, OneDrive for Business, MS Teams, Azure, Windows Server Administration, Veeam.</li>
<li>Working experience creating, managing, and troubleshooting virtual servers using VMWare.</li>
<li>Knowledge of mobile devices and MDM systems.</li>
<li>Knowledge in Cyber Security hygiene and practice of system hardening and monitoring.</li>
<li>Working knowledge of networking fundamentals, such as TCP/IP, subnetting, DNS, DHCP, WLAN and RADIUS.</li>
<li>Ability to logically breakdown complex problems to identify root causes and create sequential, actionable resolution tasks.</li>
<li>Ability to thoroughly document lessons learned, trouble ticket resolutions, and technical training materials.</li>
<li>Ability to complete complex technical tasks under pressure in a fast-paced changing environment.</li>
<li>Strong troubleshooting and problem-solving skills, including robust analytical skill with a focus on preventative actions.</li>
<li>Working after hours and weekend will be needed from time to time.</li>
<li>Outstanding ability to follow-through with tasks.</li>
<li>Strong initiative and enthusiasm and willingness to pitch in whenever needed.</li>
<li>Excellent oral written communication skills and critical thinking skills.</li>
<li>Ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.</li>
<li>Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast growing company.</li>
<li>Ability to lift up to 50 pounds.</li>
</ul>
Pay Range:
Compensation is determined based on a wide range of factors including location, job-related skills, experience, education, and training. It is not typical for an individual to be hired at or near the top of the range for their role. This pay range is specific to Northern California location. Base salary range: $120K - $140K. This position is located onsite in Hayward, CA and candidates must reside in the San Francisco Bay Area. No relocation offered.<div class="content-conclusion">Ready to Shape the Future of Healthcare?
Apply today to join Pulse Biosciences and help us redefine the boundaries of medicine with bioelectric innovation.&nbsp; To learn more about us, visit our website at <a href="http://www.pulsebiosciences.com">www.pulsebiosciences.com</a>.
We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.
PRINCIPALS ONLY; UNSOLICITED CANDIDATE SUBMISSIONS FROM RECRUITERS OR THIRD-PARTY AGENCIES WILL BE CONSIDERED FREE REFERRALS.</div>

Sr. Systems Administrator

<div class="content-intro">Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients.&nbsp; The Company’s proprietary CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.
The Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit&nbsp;<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fpulsebiosciences.com%2F&amp;esheet=53299490&amp;newsitemid=20230202005390&amp;lan=en-US&amp;anchor=pulsebiosciences.com&amp;index=2&amp;md5=be5397cf42a2c83df28cd007fa26f3d9">pulsebiosciences.com</a> to learn more.
Why Join Us?
At Pulse Biosciences, we are driven by purpose and innovation.
<ul>
<li>Our Mission: To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients. To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards.&nbsp; We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.&nbsp;</li>
<li>Our Culture: A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration.</li>
<li>Our Commitment: Hiring the best and brightest minds to advance our world-class organization.</li>
</ul>
What You Will Experience:&nbsp; 
<ul>
<li>Culture and Purpose - Purposeful and rewarding work collaborating with bright and curious minds brings us together!</li>
<li>Innovative Environment - An environment that fosters innovation to take products from concept to human use quickly!</li>
<li>Growth Opportunities - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!</li>
<li>Comprehensive Benefits - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.</li>
<li>Ownership and Rewards&nbsp;- Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.</li>
<li>Work-Life Balance -&nbsp;Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.</li>
<li>Diversity &amp; Inclusion - A commitment to providing a respectful work environment to our diverse workforce.&nbsp;</li>
</ul></div>About the Role
The Director of Clinical Affairs - Minimally Invasive Surgery Market (e.g., Thyroid) is responsible for the successful planning, directing and execution of the minimally invasive surgery market portfolio. &nbsp;The position requires maintenance of up-to-date knowledge of all applicable US, international regulation and regulatory guidance for the conduct of clinical trials in compliance with all sponsored protocols, Good Clinical Practices (GCPs), Standard Operating Procedures (SOPs), as well as in-depth product and clinical knowledge of indications. She/he brings strong leadership, problem-solving, and decision-making abilities.
To Make an Impact, You Will:
<ul>
<li>Provide operational expertise into the planning, implementation, and execution of clinical trials to obtain new or specific indication associated with the CellFX nsPFA percutaneous electrode system in accordance with project timelines, budget, and quality standards.</li>
<li>Participate in discussions with cross functional product development teams on a regular basis and create documents required for clinical readiness.</li>
<li>Contribute to the design of clinical trials including protocol development, informed consent form, case report forms/procedural worksheets, questionnaires, management of trial master files, and development of timelines, milestones, project plans/deliverables in conjunction with the research team.</li>
<li>Conduct literature review for clinical documents (e.g., Report of Priors Investigation (ROPI) and Investigator Brochure (IB).</li>
<li>Support training of internal staff, study investigators and other site personnel on the proper conduct of the trial and the review of specific product performance specifications.</li>
<li>Ensure procedures and techniques are being properly performed by investigators, site personnel, and the field team members or Contract Research Organization (CRO) to mitigate risks associated with study devices.</li>
<li>Oversee and manage key vendors such as CROs, Core Labs and contractors.</li>
<li>Ensures studies are on track for site initiation, patient recruitment and enrollment, and take corrective actions where necessary to address issues.</li>
<li>Ensure studies are conducted with high quality, according Procedures, Protocol(s) and Investigational Plans.</li>
<li>May attend surgical procedures for training purposes.</li>
<li>Problem solve and define a solution matrix for all clinical study issues as they arise.</li>
<li>Manage clinical research reporting, such as reporting to regulatory authorities and clinical research oversight entities (IRB/Ethics) as necessary.</li>
<li>Support Regulatory Affairs during the submission process.</li>
<li>Ensures clinical results are interpreted and documented clearly and concisely for regulatory submissions and publications.</li>
<li>Reviews, tracks, and approves clinical trial expenses; submit monthly clinical trial accruals to accounting.</li>
<li>Develop and manage budgets for clinical projects and adheres to company financial goals, including working with accounting for accrual expenses of minimally invasive surgical studies.</li>
<li>Hire, manage and develop Clinical Affairs internal team and contractors, as needed. Set objectives, performance goals and empower them to deliver on the Company’s strategic priorities.&nbsp; &nbsp;</li>
</ul>
To Excel, You Will Bring:
<ul>
<li>BS, BA, BSN or RN or higher degree in the Life Sciences or related disciplines.</li>
<li>10+ years of progressive industry experience with a medical device company.</li>
<li>5+ years clinical trial management experience with class II and class III medical devices.</li>
<li>Experience in managing clinical trials using ablation devices to treat soft tissue tumors and/or nodules is a plus.</li>
<li>Experience in conducting multi-center IDE clinical trials or pivotal clinical studies intended to support FDA approvals</li>
<li>Experience in writing the clinical section of a 510k and/or PMA application to the FDA is a plus</li>
<li>Strong hands-on experience in directing and managing CROs, Core Labs, and Safety Committees (e.g., DSMB and CEC).</li>
<li>Management experience building and leading a team is a plus.</li>
<li>Demonstrate ability to function as both a project leader and a project team member.</li>
<li>Proficient knowledge in devices that support ultrasound guided soft tissue ablation.</li>
<li>Demonstrate expert knowledge and comprehensive understanding of applicable GCP, ICH guidelines &amp; FDA and applicable international regulations.</li>
<li>Demonstrate expert knowledge and comprehensive understanding of US and European current practice guidelines on percutaneous soft tissue ablation for the treatment of benign and cancerous nodules</li>
<li>Knowledge of electronic data capture systems and web-based clinical trial management tools.</li>
<li>Meticulous attention to detail.</li>
<li>Ability to analyze and interpret clinical data quickly and accurately.</li>
<li>Excellent interpersonal, written, verbal communication &amp; organizational skills.</li>
<li>Ability to effectively manage time, manage resources and multi-task.</li>
<li>Ability and willingness to both "roll up sleeves" and think strategically.</li>
<li>Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast-growing company.</li>
<li>Strong program management and critical thinking skills.</li>
<li>High level computer skills required (e.g. MS Word, Excel, PowerPoint).</li>
<li>Ability to travel up to 30% of the time. Overnight domestic and/or international travel may be required</li>
<li>Ability to lift 10-15 pounds.</li>
</ul>
Pay Range:
Compensation is determined based on a wide range of factors including location, job-related skills, experience, education, and training. It is not typical for an individual to be hired at or near the top of the range for their role. This pay range is specific to Northern California location. Base salary range: $190k - $250k. This position is located in Hayward, CA and candidates must reside in the San Francisco Bay Area. No relocation offered.<div class="content-conclusion">Ready to Shape the Future of Healthcare?
Apply today to join Pulse Biosciences and help us redefine the boundaries of medicine with bioelectric innovation.&nbsp; To learn more about us, visit our website at <a href="http://www.pulsebiosciences.com">www.pulsebiosciences.com</a>.
We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.
PRINCIPALS ONLY; UNSOLICITED CANDIDATE SUBMISSIONS FROM RECRUITERS OR THIRD-PARTY AGENCIES WILL BE CONSIDERED FREE REFERRALS.</div>

Director, Clinical Affairs - Minimally Invasive Surgery Market

<div class="content-intro">Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients.&nbsp; The Company’s proprietary CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.
The Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit&nbsp;<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fpulsebiosciences.com%2F&amp;esheet=53299490&amp;newsitemid=20230202005390&amp;lan=en-US&amp;anchor=pulsebiosciences.com&amp;index=2&amp;md5=be5397cf42a2c83df28cd007fa26f3d9">pulsebiosciences.com</a> to learn more.
Why Join Us?
At Pulse Biosciences, we are driven by purpose and innovation.
<ul>
<li>Our Mission: To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients. To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards.&nbsp; We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.&nbsp;</li>
<li>Our Culture: A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration.</li>
<li>Our Commitment: Hiring the best and brightest minds to advance our world-class organization.</li>
</ul>
What You Will Experience:&nbsp; 
<ul>
<li>Culture and Purpose - Purposeful and rewarding work collaborating with bright and curious minds brings us together!</li>
<li>Innovative Environment - An environment that fosters innovation to take products from concept to human use quickly!</li>
<li>Growth Opportunities - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!</li>
<li>Comprehensive Benefits - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.</li>
<li>Ownership and Rewards&nbsp;- Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.</li>
<li>Work-Life Balance -&nbsp;Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.</li>
<li>Diversity &amp; Inclusion - A commitment to providing a respectful work environment to our diverse workforce.&nbsp;</li>
</ul></div>About the Role
The Sr. Software Test Automation Engineer will be responsible to design, develop, and maintain software test automation frameworks and automated tests for medical device software and system subsystems to improve test coverage, repeatability, efficiency, and reliability, including automation of appropriate manual test procedures and integration with continuous integration and continuous testing infrastructure.&nbsp;The ideal candidate will have a strong background in software development, software test methodologies, Python-based test automation, and embedded or real-time systems operating on QNX, Linux, or similar operating systems.&nbsp;This role will work closely with software, systems, quality, and other engineering functions to establish robust automated testing throughout the software development lifecycle, support verification and validation activities, and resolve software and system issues necessary to deliver safe, effective, high-quality, and reliable products.&nbsp;
To Make an Impact, You Will:
<ul>
<li>Determine the appropriate scope of software test automation; contribute to test strategies, plans, designs, and automation architecture; and evaluate and select appropriate tools, frameworks, and methods for automated testing.&nbsp;</li>
<li>Develop, configure, and maintain automation frameworks, test environments, fixtures, simulators, utilities, and scripts that support reusable test components, consistent execution, automated result collection, and clear reporting of test outcomes.&nbsp;</li>
<li>Work with software developers to establish and reuse automated unit and integration tests, test stubs, drivers, mocks, simulators, and other test assets, and integrate automated testing into continuous integration and continuous testing workflows.&nbsp;</li>
<li>Execute automated and manual testing, analyze results, document defects and objective evidence, and investigate failures using appropriate logging, data capture, and diagnostic capabilities to differentiate device failures from test environment, automation framework, interface, or equipment failures.&nbsp;</li>
<li>Collaborate with software, systems, electrical, quality, and other engineering disciplines to understand requirements, interfaces, intended behavior, and testability, and continuously improve unit, integration, subsystem, system, regression, and verification test processes.&nbsp;</li>
<li>Develop and execute software testing in an FDA-regulated medical device environment and support software and system verification and validation activities, including automated verification methods where appropriate.&nbsp;</li>
<li>Perform functional, interface, negative, boundary, fault-condition, regression, and risk-based testing to demonstrate that software meets defined requirements and specifications, including appropriate coverage of risk controls and safety-related requirements and maintenance of bidirectional traceability between requirements, tests, results, defects, and applicable risk controls.&nbsp;</li>
<li>Support software engineering tools and infrastructure associated with test automation, continuous integration, automated builds, regression testing, test reporting, and software deployment.&nbsp;</li>
<li>Participate in cross-functional product definition, requirements review, integration, verification, and validation activities, with particular emphasis on requirement clarity, verifiability, testability, interfaces, acceptance criteria, and complex software and system behavior.&nbsp;</li>
<li>Investigate and identify root causes of complex software, test automation, interface, and system issues using appropriate debugging and analysis tools, and clearly communicate technical issues, results, risks, and recommended actions to engineering and project leadership.&nbsp;</li>
<li>Perform code reviews, contribute to coding standards and software engineering practices for automated test infrastructure, and mentor engineers in test automation, debugging techniques, and effective use of the test framework.&nbsp;</li>
<li>Demonstrate a collaborative, adaptable, and results-oriented approach while complying with the company's Quality Policy, Quality Management System, and applicable company policies and procedures.&nbsp;</li>
</ul>
To Excel, You Will Bring:
<ul>
<li>Bachelor's degree in Computer Science, Software Engineering, Electrical Engineering, Computer Engineering, or a related technical field.</li>
<li>&nbsp;5+ years of relevant software development, software test, or test automation experience; or an equivalent combination of education and experience.&nbsp;</li>
<li>Experience developing software test automation for embedded, real-time, medical device, or other complex systems in a regulated product-development environment is strongly preferred.&nbsp;</li>
<li>Experience developing test frameworks, automated tests, and scripting applications for embedded software, subsystem interfaces, and hardware/software integrated systems using Python and Shell/Bash on Linux, BSD, QNX, or similar operating systems using x86 and ARM processor platforms.&nbsp;</li>
<li>Experience with software engineering concepts and the software development lifecycle, including requirements, design, implementation, testing, and support.&nbsp;</li>
<li>Familiarity with version control, test management, and issue-tracking tools (e.g., Git, Bitbucket, Jira).&nbsp;</li>
<li>Demonstrated commitment to developing robust, reliable, and maintainable products and test systems.&nbsp;&nbsp;</li>
<li>Strong analytical, problem-solving, critical-thinking, and communication skills, including experience writing technical documentation.&nbsp;</li>
<li>Working knowledge of good software engineering development practices, including software development in an FDA-regulated environment.&nbsp;&nbsp;</li>
<li>Ability to work independently and collaboratively, exercise good judgement and initiative, manage multiple priorities, and adapt to changing requirements with minimal direction.&nbsp;&nbsp;</li>
<li>Ability to lift 10-15 pounds.</li>
</ul>
Pay Range:
Compensation is determined based on a wide range of factors including location, job-related skills, experience, education, and training. It is not typical for an individual to be hired at or near the top of the range for their role. This pay range is specific to Northern California location. Base salary range: $130k - $160k. This position is located onsite in Hayward, CA and candidates must reside in the San Francisco Bay Area. No relocation offered.<div class="content-conclusion">Ready to Shape the Future of Healthcare?
Apply today to join Pulse Biosciences and help us redefine the boundaries of medicine with bioelectric innovation.&nbsp; To learn more about us, visit our website at <a href="http://www.pulsebiosciences.com">www.pulsebiosciences.com</a>.
We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.
PRINCIPALS ONLY; UNSOLICITED CANDIDATE SUBMISSIONS FROM RECRUITERS OR THIRD-PARTY AGENCIES WILL BE CONSIDERED FREE REFERRALS.</div>

Sr. Software Test Automation Engineer

<div class="content-intro">Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients.&nbsp; The Company’s proprietary CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.
The Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit&nbsp;<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fpulsebiosciences.com%2F&amp;esheet=53299490&amp;newsitemid=20230202005390&amp;lan=en-US&amp;anchor=pulsebiosciences.com&amp;index=2&amp;md5=be5397cf42a2c83df28cd007fa26f3d9">pulsebiosciences.com</a> to learn more.
Why Join Us?
At Pulse Biosciences, we are driven by purpose and innovation.
<ul>
<li>Our Mission: To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients. To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards.&nbsp; We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.&nbsp;</li>
<li>Our Culture: A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration.</li>
<li>Our Commitment: Hiring the best and brightest minds to advance our world-class organization.</li>
</ul>
What You Will Experience:&nbsp; 
<ul>
<li>Culture and Purpose - Purposeful and rewarding work collaborating with bright and curious minds brings us together!</li>
<li>Innovative Environment - An environment that fosters innovation to take products from concept to human use quickly!</li>
<li>Growth Opportunities - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!</li>
<li>Comprehensive Benefits - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.</li>
<li>Ownership and Rewards&nbsp;- Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.</li>
<li>Work-Life Balance -&nbsp;Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.</li>
<li>Diversity &amp; Inclusion - A commitment to providing a respectful work environment to our diverse workforce.&nbsp;</li>
</ul></div>About the Role
The Corporate Paralegal/Sr. Corporate Paralegal is a core member of the Legal team, reporting directly to the General Counsel &amp; Corporate Secretary and partnering with Finance, HR, Clinical, Commercial and other internal and external stakeholders. This individual supports the Company’s corporate and security matters, including SEC reporting, Section 16 filings, insider trading, and board processes; manages key legal operations, including contracts, corporate records, and entity management systems; and owns the day-to-day administration of the Company’s equity programs.&nbsp; Success in this role will require meticulous attention to detail, sound judgement, and discretion. This is a unique opportunity to build scalable processes at a Nasdaq-listed medical device company pioneering nanosecond Pulsed Field Ablation (nsPFA) technology.
To Make an Impact, You Will:
<ul>
<li>Support the Company’s corporate and securities matters, including SEC filings, public company reporting, financing, capital markets transactions, and related due diligence and data room management.</li>
<li>Prepare and file Section 16 reports (Forms 3, 4, and 5), manage EDGAR Next access, and help administer our Insider Trading Policy (blackout periods, pre-clearance, and Rule 10b5-1 plans).</li>
<li>Support preparation of our SEC filings (for example, Forms 10-K, 10-Q, 8-K, S-3, and S-8 and proxy statements) and annual D&amp;O questionnaires.</li>
<li>Support Board, committee, and annual stockholder meetings, including materials, consents, draft minutes, and annual meeting logistics.</li>
<li>Administer the Company’s contract lifecycle management system (LinkSquares) and, under attorney supervision, draft and support negotiation of routine agreements, including, NDAs, MTAs, consulting, and vendor agreements using Company templates.</li>
<li>Support Legal Department operations, including maintenance of templates and policies, outside counsel billing, project tracking, legal research, legal technology tools, and recurring reports and data requests, including those for auditors and our Board of Directors.</li>
<li>Own day-to-day administration of our equity incentive plans and ESPP, including award documentation and approvals, vesting, exercises, settlements, and reconciliation with our transfer agent and Finance Department.</li>
<li>Serve as primary contact with our transfer agent on share issuances, related matters, and support employee education regarding equity programs.</li>
<li>Manage entity management, corporate records, and document execution (approvals, signatures, notarization, and legalization) for Pulse Bio and its subsidiaries.</li>
<li>Support our healthcare compliance program (for example, Open Payments reporting and HCP fair market value documentation), Code of Conduct training and acknowledgments, records retention, and legal holds.</li>
</ul>
To Excel, You Will Bring:
<ul>
<li>Bachelor’s degree and paralegal qualifications under Cal. Bus. &amp; Prof. Code § 6450(c) required; ABA-approved paralegal certificate preferred.</li>
<li>4+ years of experience as a corporate or securities paralegal or stock plan administrator at a law firm and/or public company; medical device or life sciences compliance experience (for example, Open Payments, AdvaMed Code) a plus.</li>
<li>Hands-on experience with Section 16 filings, insider trading policy administration, and public company board and annual meeting processes.</li>
<li>Certified Equity Professional (CEP) and/or experience with equity administration platforms such as Shareworks or E*TRADE a strong plus.</li>
<li>Advanced Microsoft Office skills, particularly Word and Excel, and demonstrated ability adopting legal technology, including AI-enabled tools. LinkSquares experience a plus.</li>
<li>Solid understanding of corporate formalities, security matters, contracts, and legal research methods.</li>
<li>Notary license a</li>
<li>Self-driven, curious, and positive, with a passion for building scalable processes and managing competing deadlines in a fast-paced, lean environment.</li>
<li>Detail-oriented, with sound judgement and discretion in handling confidential information and in identifying and escalating issues promptly.</li>
<li>Excellent written and verbal communication skills, with the ability to explain legal requirements clearly and diplomatically to employees, executives and other stakeholders.</li>
<li>Excited to contribute to the Company’s mission and its pioneering nsPFA technology.</li>
<li>Able to lift 15-20 pounds.</li>
</ul>
Pay Range:
Compensation is determined based on a wide range of factors including location, job-related skills, experience, education, and training. It is not typical for an individual to be hired at or near the top of the range for their role. This pay range is specific to Northern California location. Base salary range: $100k - $150k. This position is located onsite in Hayward, CA and candidates must reside in the San Francisco Bay Area. No relocation offered.<div class="content-conclusion">Ready to Shape the Future of Healthcare?
Apply today to join Pulse Biosciences and help us redefine the boundaries of medicine with bioelectric innovation.&nbsp; To learn more about us, visit our website at <a href="http://www.pulsebiosciences.com">www.pulsebiosciences.com</a>.
We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.
PRINCIPALS ONLY; UNSOLICITED CANDIDATE SUBMISSIONS FROM RECRUITERS OR THIRD-PARTY AGENCIES WILL BE CONSIDERED FREE REFERRALS.</div>

Corporate Paralegal/Sr. Corporate Paralegal

<div class="content-intro">Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients.&nbsp; The Company’s proprietary CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.
The Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit&nbsp;<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fpulsebiosciences.com%2F&amp;esheet=53299490&amp;newsitemid=20230202005390&amp;lan=en-US&amp;anchor=pulsebiosciences.com&amp;index=2&amp;md5=be5397cf42a2c83df28cd007fa26f3d9">pulsebiosciences.com</a> to learn more.
Why Join Us?
At Pulse Biosciences, we are driven by purpose and innovation.
<ul>
<li>Our Mission: To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients. To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards.&nbsp; We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.&nbsp;</li>
<li>Our Culture: A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration.</li>
<li>Our Commitment: Hiring the best and brightest minds to advance our world-class organization.</li>
</ul>
What You Will Experience:&nbsp; 
<ul>
<li>Culture and Purpose - Purposeful and rewarding work collaborating with bright and curious minds brings us together!</li>
<li>Innovative Environment - An environment that fosters innovation to take products from concept to human use quickly!</li>
<li>Growth Opportunities - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!</li>
<li>Comprehensive Benefits - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.</li>
<li>Ownership and Rewards&nbsp;- Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.</li>
<li>Work-Life Balance -&nbsp;Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.</li>
<li>Diversity &amp; Inclusion - A commitment to providing a respectful work environment to our diverse workforce.&nbsp;</li>
</ul></div>About the Role
The Sr. Process Development Engineer will be responsible to bridge early-stage device development and commercial-grade manufacturing. This individual will take first-in-human catheter devices and refine them into robust, manufacturable products ready for commercial launch. The ideal candidate will bring deep catheter engineering expertise, a manufacturing mindset, and a proven track record of successful medical device design transfer.
To Make an Impact, You Will:
<ul>
<li>Lead process development activities to transition early-stage catheter devices from first-in-human configurations to commercially viable, scalable products.</li>
<li>Perform DFM/DFA analyses and tolerance stack-up studies (worst-case and statistical) to eliminate producibility risks, define critical dimensions, and establish component acceptance criteria.</li>
<li>Develop and maintain detailed component specifications, drawing requirements, and incoming inspection criteria, including AQL sampling plans, in alignment with device performance requirements and supplier capabilities.</li>
<li>Characterize and optimize catheter manufacturing processes including extrusion, braiding, tip forming, thermal bonding, adhesive joining, and laser cutting to achieve robust, repeatable outcomes.</li>
<li>Develop and optimize electrical assembly processes for catheter-integrated components, including fine-gauge wire termination, surface mount component placement, and high- and low-voltage cable assembly fabrication in compliance with applicable industry workmanship standards.</li>
<li>Partner with Manufacturing Engineering on process validation (IQ, OQ, PQ) and process FMEAs; contribute to protocols, risk documentation, and control definitions to ensure regulatory compliance.</li>
<li>Collaborate with Manufacturing Engineering to establish SPC methods, capability studies (Cp, Cpk), yield targets, and build monitoring frameworks that support production stability and COGS objectives.</li>
<li>Develop inspection gauges and conduct MSA/gauge R&amp;R studies to validate measurement system capability.</li>
<li>Evaluate and qualify raw materials, adhesives, and components; assess material compatibility, processability, and biocompatibility implications.</li>
<li>Initiate and manage engineering change orders (ECOs) to implement process improvements while maintaining design history file integrity.</li>
<li>Ensure components and processes under development are compatible with sterilization methods (EO, gamma, e-beam) and packaging requirements in collaboration with quality and regulatory teams.</li>
<li>Apply lean manufacturing principles to reduce waste and improve cycle times in preparation for commercial scale-up.</li>
<li>Partner with suppliers and contract manufacturers to evaluate process capabilities, establish manufacturing requirements, and drive continuous improvement.</li>
<li>Create and maintain manufacturing work instructions, assembly procedures, and process travelers to support design transfer and production readiness.</li>
<li>Collaborate cross-functionally with R&amp;D, quality, regulatory, and manufacturing teams to align process activities with design controls and program timelines.</li>
<li>Mentor junior engineers and technicians on process-related problem solving and root cause analysis.</li>
</ul>
To Excel, You Will Bring:
<ul>
<li>Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Materials Science, Manufacturing Engineering, or a related field; Master's degree preferred.</li>
<li>Minimum 5 years of medical device process development or manufacturing engineering experience, with at least 3 years focused on catheter-based devices, including demonstrated experience taking a device from early-stage development to commercial manufacturing.</li>
<li>Hands-on experience with catheter manufacturing processes including extrusion, braiding, thermal bonding, tip forming, adhesive assembly, and laser processing.</li>
<li>Proficiency in tolerance stack-up analysis (worst-case and statistical) and working knowledge of statistical methods (Cp/Cpk, SPC, gauge R&amp;R); DOE experience a plus.</li>
<li>Experience supporting process validation (IQ, OQ, PQ) in a regulated medical device environment.</li>
<li>Familiarity with FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971 risk management requirements.</li>
<li>Experience developing component specifications and working with suppliers to establish and verify manufacturing capabilities.</li>
<li>Proficient in CAD tools (SolidWorks preferred) and GD&amp;T per ASME Y14.5; familiarity with statistical software (Minitab or equivalent) preferred.</li>
<li>Working knowledge of catheter materials including thermoplastic polymers (PEBAX, nylon, polyurethane, PTFE), metallic components (nitinol, stainless steel, platinum-iridium), and adhesive systems.</li>
<li>Strong analytical and problem-solving skills; experience with root cause analysis tools including FMEA, fishbone diagrams, 8D, and 5 Whys.</li>
<li>Cleanroom experience preferred (ISO Class 7 or 8); strong project management skills with ability to manage multiple concurrent programs.</li>
<li>Strong written and verbal communication skills; able to work independently and collaboratively in a fast-paced, cross-functional environment.</li>
<li>Ability to work conscientiously and with minimal direction, using good judgement and taking initiative to accomplish assigned tasks.</li>
<li>Ability to work as a team member, multi-task, and adapt to the changing priorities of a dynamic, fast-growing company.</li>
<li>Occasional travel may be required up to 15% of the time, primarily for supplier qualification, contract manufacturing, and design transfer activities.</li>
<li>Ability to lift 10-15 pounds.</li>
</ul>
Pay Range:
Compensation is determined based on a wide range of factors including location, job-related skills, experience, education, and training. It is not typical for an individual to be hired at or near the top of the range for their role. This pay range is specific to Northern California location. Base salary range: $130k-$155k. This position is located onsite in Hayward, CA and candidates must reside in the San Francisco Bay Area. No relocation offered.<div class="content-conclusion">Ready to Shape the Future of Healthcare?
Apply today to join Pulse Biosciences and help us redefine the boundaries of medicine with bioelectric innovation.&nbsp; To learn more about us, visit our website at <a href="http://www.pulsebiosciences.com">www.pulsebiosciences.com</a>.
We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.
PRINCIPALS ONLY; UNSOLICITED CANDIDATE SUBMISSIONS FROM RECRUITERS OR THIRD-PARTY AGENCIES WILL BE CONSIDERED FREE REFERRALS.</div>

Sr. Process Development Engineer, Catheter Engineering

<div class="content-intro">Pulse Biosciences (Nasdaq: PLSE): Join the Future of Bioelectric Medicine
Pulse Biosciences is a novel bioelectric medicine company committed to health innovation that has the potential to improve the quality of life for patients.&nbsp; The Company’s proprietary CellFX® nsPFA™ (nanosecond Pulsed Field Ablation) technology delivers nanosecond pulses of electrical energy to non-thermally ablate cells while sparing adjacent noncellular tissue.
The Company is actively pursuing the development of its CellFX nsPFA technology for use in the surgical treatment of atrial fibrillation and percutaneously in a select few other markets where it could have a profound positive impact on healthcare for both patients and providers. Visit&nbsp;<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fpulsebiosciences.com%2F&amp;esheet=53299490&amp;newsitemid=20230202005390&amp;lan=en-US&amp;anchor=pulsebiosciences.com&amp;index=2&amp;md5=be5397cf42a2c83df28cd007fa26f3d9">pulsebiosciences.com</a> to learn more.
Why Join Us?
At Pulse Biosciences, we are driven by purpose and innovation.
<ul>
<li>Our Mission: To build a viable Company that designs, produces, and commercializes nano-pulse technology to improve and extend the lives of patients. To solve the needs of patients, physicians, and healthcare providers with high quality and high reliability products and services, developed in accordance with rigorous scientific, engineering, and clinical standards.&nbsp; We exist to make a positive difference in the lives of patients, physicians, healthcare providers, shareholders and our Pulse Biosciences team members.&nbsp;</li>
<li>Our Culture: A community of creative, forward-thinking individuals tackling challenges with ingenuity and collaboration.</li>
<li>Our Commitment: Hiring the best and brightest minds to advance our world-class organization.</li>
</ul>
What You Will Experience:&nbsp; 
<ul>
<li>Culture and Purpose - Purposeful and rewarding work collaborating with bright and curious minds brings us together!</li>
<li>Innovative Environment - An environment that fosters innovation to take products from concept to human use quickly!</li>
<li>Growth Opportunities - Learning culture focusing on professional and personal growth and development that you can only get in a startup-like environment!</li>
<li>Comprehensive Benefits - A variety of health insurance plans and supplemental insurance options, and 401k retirement savings plan.</li>
<li>Ownership and Rewards&nbsp;- Stock options awards and Employee Stock Purchase Plan (ESPP) to share in our success.</li>
<li>Work-Life Balance -&nbsp;Enjoy paid time off, paid holidays, flexible work schedule and wellness program, including onsite gym and mindfulness classes.</li>
<li>Diversity &amp; Inclusion - A commitment to providing a respectful work environment to our diverse workforce.&nbsp;</li>
</ul></div>About the Role
As the Sr. Clinical Research Associate (Sr. CRA) you’ll be responsible for managing and monitoring activities that will lead to successful execution of clinical studies at US and international clinical sites. You will monitor patient recruitment, data and study related information related to clinical sites and study participation. Ensure that duties are performed in accordance with the Code of Federal Regulations (CFR) of the Food and Drug Administration (FDA) and the International Conference on Harmonization - Good Clinical Practice (ICH-GCP).
To Make an Impact, You Will:
<ul>
<li>Provide case support to research sites across multiple studies with minimal guidance.</li>
<li>Prepare and develop project and study-related documents including informed consent forms, CRFs, study guides, study reference binders, and patient diaries.</li>
<li>Coordinate review of data listings and preparation of interim and final clinical study reports.</li>
<li>Be responsible for monitoring clinical studies, which includes review of case report forms (CRFs) both paper and/or electronic data capture (EDC), and source documentation to ensure adherence to the protocol and scientific validity of the data.</li>
<li>Be responsible for developing study specific monitoring tools and other related documents.</li>
<li>Deliver high quality written monitoring reports, confirmation and follow-up letters within the timelines of SOPs and monitoring plans.</li>
<li>Ensure that all missing action items (MAIs) from monitoring visits are closed within the timelines of monitoring plans.</li>
<li>Be responsible for reviewing and approving essential regulatory documents across multiple studies.</li>
<li>Assist the project team in developing study metrics to ensure the efficient execution of a clinical trial.</li>
<li>Oversee clinical data to ensure queries are closed within stipulated timelines of study goals</li>
<li>Provide clinical support for submission of trials to IRB/IEC and regulatory authorities.</li>
<li>Ensure adherence to study timeline across multiple studies.</li>
<li>Coach and mentor other Clinical Research Associates (CRAs) in development and training.</li>
<li>Maintain strong working knowledge of protocols and product development across multiple studies.</li>
<li>Demonstrate ability to coordinate, organize, communicate, and manage site activities, with knowledge of when to escalate issues to management or clinical team.</li>
<li>Demonstrate an excellent working knowledge of clinical research processes, Good Clinical Practices, International Committee on Harmonization Guidelines, federal regulations and applicable local laws pertaining to clinical research investigations.</li>
<li>Verify the rights and well-being of study subjects are protected and verifies that written informed consent was obtained before each subject’s participation in the study.</li>
<li>Perform Investigational Product accountability, including product storage, inventory, return/destruction, and dispensing/receipt records.</li>
<li>Ensure compliance in reporting adverse events/serious adverse events according to the protocol and applicable regulatory agencies.</li>
<li>Manage Protocol Deviation documentation, tracking, and escalation.</li>
<li>Participate in site audits, as requested.</li>
</ul>
To Excel, You Will Bring:&nbsp;
<ul>
<li>BS/BA degree or equivalent experience.</li>
<li>5+ years’ experience directly supporting clinical research or relevant experience in medical/scientific area.</li>
<li>At least 3 years of CRA experience in device or biotech clinical trials.</li>
<li>Cardiovascular device experience preferred</li>
<li>Certified as a CRA, e.g. CCRA, CCRP, or other CRA certification strongly preferred.</li>
<li>Proficient in Acrobat Adobe, Microsoft Word, Excel, Power Point, and Smartsheet; and the ability to quickly become proficient in a variety of other computer software programs.</li>
<li>Knowledge of FDA and international regulations and guidelines including, but not limited to, clinical strategy, GCPs, SOPs, submissions, product launch, labeling, advertising and promotion, product vigilance and medical device reporting. </li>
<li>Proficient in using EDC and CTMS systems.</li>
<li>Working knowledge of FDA, European Regulatory and EC procedures, as applicable.</li>
<li>Excellent oral, written communication skills with strong presentation skills.</li>
<li>Clear and systematic thinking that demonstrates good judgment and problem-solving competencies.</li>
<li>Excellent critical thinking analytical skills.</li>
<li>Strong organizational skills with the ability to work conscientiously and with minimal direction, using good judgment, taking initiative to accomplish short and long-range projects, and recommend actions with minimal direction.</li>
<li>Ability to work as a team member, multi-task and be very flexible to adapt to the ever-changing work priorities and requirements of a dynamic, fast growing company.</li>
<li>Flexibility in work hours and readiness to travel 30%-50% of the time, overnight and/or international travel may be required.</li>
<li>Ability to lift 10-15 pounds.</li>
</ul><div class="content-conclusion">Ready to Shape the Future of Healthcare?
Apply today to join Pulse Biosciences and help us redefine the boundaries of medicine with bioelectric innovation.&nbsp; To learn more about us, visit our website at <a href="http://www.pulsebiosciences.com">www.pulsebiosciences.com</a>.
We provide equal employment opportunities (EEO) to all persons regardless of race, age, color, gender, sexual orientation, national origin, physical or mental disability, religion, or any other characteristic protected by federal, state or local law. We will make reasonable accommodations for qualified individuals with disabilities.
PRINCIPALS ONLY; UNSOLICITED CANDIDATE SUBMISSIONS FROM RECRUITERS OR THIRD-PARTY AGENCIES WILL BE CONSIDERED FREE REFERRALS.</div>

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