Penumbra is a global healthcare company focused on innovative medical devices to improve patient outcomes. Established in 2004, Penumbra has been a trailblazer in developing groundbreaking technologies for neurovascular and peripheral vascular interventions. Their commitment to advancing medical solutions has revolutionized the field of minimally invasive procedures and continues to drive advancements in patient care worldwide.

penumbra

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<p><strong>General Summary</strong></p>
<p>We are seeking an experienced Supplier Quality Engineering Manager to help manage our Supplier Controls. This position is responsible for the effective execution, oversight, and continuous improvement of supplier quality processes and controls that support manufacturing operations and regulatory compliance.</p>
<p>The manager will own key supplier quality processes, including Approved Supplier List (ASL) management, supplier onboarding and qualification controls, and supplier performance monitoring. This individual will ensure that established processes are consistently executed, appropriately controlled, and compliant with quality management system requirements while driving improvements that enhance efficiency, standardization, and operational effectiveness.</p>
<p>The role will play an important part in modernizing supplier quality processes and systems, leveraging enterprise platforms and cross-functional partnerships to simplify workflows, strengthen controls, and improve how supplier quality activities are managed. The manager will also lead a dedicated team of Supplier Quality Engineers supporting supplier quality operations and the needs of Operational Procurement across multiple manufacturing sites.</p>
<p>The successful candidate will bring strong supplier quality engineering fundamentals, practical experience managing quality processes, effective people leadership, and a continuous improvement mindset.</p>
<p><strong>Primary Responsibilities</strong></p>
<p><strong>Supplier Quality Controls </strong></p>
<ul type="disc">
<li>Own and manage supplier quality control processes, including ASL maintenance, supplier addition requests, supplier approval status, and associated supplier qualification controls.</li>
<li>Ensure supplier onboarding, approval, and qualification activities are executed consistently, efficiently, and in accordance with established risk-based requirements and quality management system procedures.</li>
<li>Maintain effective governance of supplier quality records, approval workflows, supplier status, and associated documentation to ensure traceability, accuracy, and regulatory compliance.</li>
<li>Establish and maintain standardized processes, clear accountability, and appropriate controls to ensure reliable execution and sustained compliance.</li>
<li>Monitor process effectiveness, address execution gaps, and drive improvements in process adherence, turnaround times, and operational efficiency.</li>
</ul>
<p><strong>Supplier Quality Process Improvement</strong></p>
<ul type="disc">
<li>Drive the improvement and modernization of supplier quality processes to enhance efficiency, simplify workflows, strengthen controls, and support evolving business needs.</li>
<li>Improve the utilization and effectiveness of enterprise systems, including SAP, AssurX, TrackWise, and other applicable quality management platforms, to support supplier quality activities.</li>
<li>Partner with Quality Engineering leadership, IT, Quality Systems, and cross-functional stakeholders to identify improvement opportunities, define business requirements, and implement practical, sustainable solutions.</li>
<li>Support the transition of manual supplier quality activities to streamlined, electronically managed processes that maintain appropriate quality system controls and regulatory compliance.</li>
<li>Coordinate process changes, system implementation activities, validation support, and associated QMS documentation updates with appropriate functional stakeholders.</li>
<li>Ensure improvements are effectively implemented, adopted, and sustained through standardized practices, training, and ongoing process monitoring.</li>
</ul>
<p><strong>Supplier Quality Performance Monitoring </strong></p>
<ul type="disc">
<li>Manage standardized processes for monitoring, tracking, and reporting supplier quality performance, including supplier nonconformances, corrective actions, supplier changes, and other established quality indicators.</li>
<li>Ensure supplier quality data is accurate, consistent, and accessible to support supplier performance evaluations, trend analysis, and management decision-making.</li>
<li>Collaborate with manufacturing sites to ensure consistent application of supplier quality processes, controls, and performance monitoring practices.</li>
<li>Support supplier quality activities across domestic and international manufacturing locations, including supplier onboarding, supplier-related requests, receiving quality issues, and supplier changes.</li>
<li>Partner with site Quality Engineering, Incoming Quality Control, and Operational Procurement teams to address process inconsistencies and improve cross-site coordination.</li>
</ul>
<p><strong>Team Leadership</strong></p>
<ul type="disc">
<li>Lead, coach, and develop a team of Supplier Quality Engineers responsible for supplier controls and assigned operational support activities.</li>
<li>Provide dedicated engineering support for Supplier Change assessments, incoming quality nonconformances, and other supplier quality activities in coordination with Supplier Quality Engineering leadership.</li>
<li>Ensure timely, technically sound, and risk-based execution of assigned supplier quality activities in accordance with established procedures and quality system requirements.</li>
<li>Partner closely with other SQE Managers and Operational Procurement to align priorities, balance resources, and support timely resolution of supplier quality needs.</li>
<li>Establish clear team expectations, develop employee capabilities, and foster a culture of accountability, collaboration, and continuous improvement.</li>
</ul>
<p><strong>Required Qualifications</strong></p>
<ul type="disc">
<li>Bachelor's degree in Engineering, Science, or a related technical discipline.</li>
<li>8+ years of progressive experience in Supplier Quality Engineering, Quality Engineering, or related quality functions within a regulated manufacturing environment.</li>
<li>Strong working knowledge of supplier quality management processes, including supplier qualification, supplier onboarding and approval, supplier controls, supplier performance monitoring, supplier changes, and nonconformance management.</li>
<li>Experience managing or providing technical leadership to quality engineering teams.</li>
<li>Demonstrated ability to manage quality processes, ensure procedural compliance, and drive improvements in operational execution.</li>
<li>Experience working with ERP and/or electronic quality management systems in support of quality processes and controls.</li>
<li>Working knowledge of ISO 13485, FDA Quality Management System Regulation (QMSR), and applicable supplier control requirements.</li>
<li>Strong organizational, analytical, communication, and cross-functional collaboration skills.</li>
</ul>
<p><strong>Preferred Qualifications</strong></p>
<ul type="disc">
<li>Supplier Quality Engineering experience in medical device manufacturing.</li>
<li>Experience managing Approved Supplier Lists, supplier qualification records, supplier approval workflows, and related QMS processes.</li>
<li>Experience with SAP, AssurX, TrackWise, MasterControl, or comparable enterprise and quality management systems.</li>
<li>Experience improving quality workflows, defining business requirements, and supporting electronic system enhancements and implementation.</li>
<li>Experience establishing or maintaining supplier performance metrics, scorecards, and quality reporting.</li>
<li>Experience supporting supplier quality activities across multiple manufacturing locations.</li>
<li>Demonstrated success improving quality process efficiency, standardization, and execution.</li>
<li>ASQ certification, Lean Six Sigma certification, or relevant continuous improvement training.</li>
</ul>
<p><strong>Leadership Expectations</strong></p>
<p>The Supplier Controls Manager is expected to demonstrate strong ownership of supplier quality processes, ensuring they are effectively executed, appropriately controlled, and continuously improved.</p>
<p>This individual should possess the technical judgment to evaluate supplier quality risks, the operational discipline to maintain reliable and compliant processes, and the initiative to improve and modernize established ways of working.</p>
<p>Success in this role requires balancing daily supplier quality responsibilities with process improvement, effective cross-functional collaboration, employee development, and support for manufacturing operations.</p>
<p><strong>Location and Salary </strong></p>
<ul>
<li><strong>Location: </strong>Alameda, CA</li>
<li><strong>Annual Base Salary Range: </strong>$138,000 to $203,000</li>
<li>We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.</li>
</ul>
<p><strong>Working Conditions</strong></p>
<ul>
<li>General office, laboratory, and cleanroom environments</li>
<li>Willingness and ability to work on site. May have business travel from 0% - 25%</li>
<li>Potential exposure to blood-borne pathogens</li>
<li>Requires some lifting and moving of up to 25 pounds</li>
<li>Must be able to move between buildings and floors.</li>
<li>Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.</li>
<li>Must be able to read, prepare emails, and produce documents and spreadsheets.</li>
<li>Must be able to move within the office and access file cabinets or supplies, as needed.</li>
<li>Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.</li>
</ul>
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Supplier Quality Engineering Manager – Supplier Controls

<p>Under minimal supervision, the IT Full-stack Developer will design and develop applications, working with business users to understand and compile requirements.&nbsp;</p>
<p>The IT Full-stack Developer will have primary responsibility for maintaining applications for various business departments.</p>
<p><span style="text-decoration: underline;"><strong>Specific Duties and Responsibilities</strong></span><br>• Build and maintain a React-based client for web and mobile based applications.&nbsp;<br>• Create and manage low code applications using Microsoft Power Apps.&nbsp;<br>• Create and maintain RPA workflows preferably using Microsoft Power Automate.&nbsp;<br>• Take designs from concept to implementation in enterprise business applications, working with teammates from a wide range of disciplines.<br>• Develop, configure, deploy, maintain, and troubleshoot Azure Function Apps and related cloud integrations, ensuring reliable performance across enterprise applications.<br>• Help to diagnose, fix, and learn from service issues in production.<br>• Document and implement API calls to and from various enterprise applications.<br>• Solicit and apply internal customer feedback to improve the application user experience.<br>• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.<br>• Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.&nbsp;<br>• Ensure other members of the department to follow the QMS, regulations, standards, and procedures.&nbsp;<br>• Perform other work-related duties as assigned.</p>
<p><span style="text-decoration: underline;"><strong>Position Qualifications: Required</strong></span><br>• Bachelor's degree in computer science or related field with 3+ years of experience developing applications, or an equivalent combination of education and experience.<br>• Experience taking designs from concept to implementation of enterprise application solutions<br>• Experience with JavaScript, React, Node.js<br>• Experience working with relational databases, preferably Postgres<br>• Experience with Cloud (preferably Azure), Docker/Kubernetes, NoSQL databases, Microsoft Power Apps, Microsoft Power Automate<br>• Proven success in development and deployment of backend / frontend platforms in a SaaS environment<br>• Self-starter and comfortable to work autonomously or collaboratively with cross functional teams, with agile development approach<br>• Highly developed teamwork skills with experience working in cross-collaborative teams<br>• Demonstrated success in owning projects end-to-end, including working with non-technical<br>• Medical device, pharmaceutical, biotech, or other regulated industry experience desired<br>• Strong oral, written, and interpersonal communication skills<br>• High degree of accuracy and attention to detail<br>• Proficiency with MS Word, Excel, and PowerPoint<br>• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously</p>
<p><span style="text-decoration: underline;"><strong>Working Conditions</strong></span><br>• General office environment.<br>• Willingness and ability to work on site.<br>• Requires some lifting and moving of up to 10 pounds.<br>• Must be able to move between buildings and floors.<br>• Must be able to remain stationary and use a computer or other standard office&nbsp;<br>equipment, such as a printer or copy machine, for an extensive period of time each day.&nbsp;<br>• Must be able to read, prepare emails, and produce documents and spreadsheets.&nbsp;<br>• Must be able to move within the office and access file cabinets or supplies, as needed.<br>• Must be able to communicate and exchange accurate information with employees at all&nbsp;<br>levels on a daily basis.</p>
<p><span style="text-decoration: underline;"><strong>Starting Base Salary is $95,000 to $145,000 &nbsp;</strong></span><br>We offer a competitive compensation package plus a benefits and equity program, when applicable. &nbsp;<br>Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.</p>

IT Full Stack Developer

Principal Quality Engineer

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<p>The Network Operations Engineer will focus on providing operational and implementation support for Network, Wireless, firewall, DNS, DHCP, LAN, incidents, and changes.&nbsp;</p>
<p><span style="text-decoration: underline;"><strong>Specific Duties and Responsibilities&nbsp;</strong></span><br>• Monitor network infrastructure, troubleshoot, and handle user incidents actively during company business hours.&nbsp;<br>• Provide medium to high complexity network support activities including occasional offshift support in case of major outage reported.&nbsp;<br>• Work closely with Network Engineering, Network Security and Administration maintenance tasks and participate in process improvement.&nbsp;<br>• Perform medium to high complexity network changes and implementations.&nbsp;<br>• Participate in the network technology design process.&nbsp;<br>• Analyze potential changes and enhancements to network software and hardware to determine impact on existing production environment.&nbsp;<br>• Work as a member of a project team on business projects&nbsp;<br>• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.&nbsp;<br>• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.&nbsp;<br>• Ensure other members of the department follow the QMS, regulations, standards, and procedures.&nbsp;<br>• Perform other work-related duties as assigned. &nbsp;</p>
<p><span style="text-decoration: underline;"><strong>Position qualifications: Required</strong></span><br>• Bachelor’s degree in computer engineering or related field with 5+ years of experience, or equivalent combination of education and experience &nbsp;&nbsp;<br>• 5+ years of experience in operations and managing Network devices, firewalls infrastructure.&nbsp;<br>• 5+ years of experience installing and building Network infrastructure.&nbsp;<br>• In-depth knowledge of network hardware and software technologies and best practices is required.<br>• Good knowledge of PAN firewalls architecture, ACLs, policies, NATs, IPSEC VPNs, Global protect VPNs<br>• Understanding and practical experience with technologies such as Cisco SDA, ISE, VXLAN etc.&nbsp;<br>• Knowledge of a network technology discipline (e.g., IP Routing and Switching, Routing Protocols-OSPF, BGP, WAN, IPSEC, PAN Firewall, Packet Analysis, SD Access, DNAC, Cisco ISE, Infrastructure, IT Tools, and other relevant technologies.&nbsp;<br>• Excellent troubleshooting skills in identifying and resolving complex networking issues&nbsp;<br>• Strong understanding of how DNS works and experience in deploying and managing the internal and external DNS environments&nbsp;<br>• Experience in managing different Load Balancer solutions.&nbsp;<br>• Experience with cloud networking and cloud connectivity.&nbsp;<br>• Good team player and able to take accountability of tasks assigned and follow through to completion.&nbsp;<br>• Strong communication and customer facing skills (written, verbal, and formal presentation)&nbsp;<br>• Proactively acquire an in-depth understanding of the organization and its processes as well as develop an understanding of incidents and change management principles and organization best practices.&nbsp;</p>
<p><span style="text-decoration: underline;"><strong>Position qualifications: Preferred</strong></span><br>• Knowledge of Routing and Switching design preferred • R&amp;S and/or DC CCNA is required, CCNP preferred.<br>• Experience on SolarWinds IT infrastructure monitoring and provisioning is preferred&nbsp;<br>• LAN switching including VLAN, VTP, STP etc. is preferred&nbsp;<br>• Solid understanding of routing protocols ISIS, OSPF, BGP is preferred&nbsp;<br>• Good working knowledge of Wireless network includes WLC 9800, 3500 Access points 9120 is preferred&nbsp;<br>• Solid knowledge of Cisco Catalyst 9000 series, Palo Alto firewalls, Nexus 93k series, APC UPS, OOB network is preferred&nbsp;<br>• Test and validation experience (Network hardware or software/OS) is preferred&nbsp;<br>• Scripting/programing skills will be a PLUS&nbsp;<br>• Medical device, pharmaceutical, biotech, or other regulated industry experience desired&nbsp;<br>&nbsp;</p>
<p><span style="text-decoration: underline;"><strong>Working Conditions &nbsp;&nbsp;</strong></span><br>• General office environment.&nbsp;<br>• Willingness and ability to work on site. May have business travel from 0% - 10%. Ability to be available for on-call duty during off hours as part of a rotating schedule.&nbsp;<br>• Flexibility to switch weekend days off with weekdays when necessary to avoid disruption to 24/7 production environments&nbsp;<br>• Potential exposure to blood-borne pathogens. &nbsp;<br>• Requires some lifting and moving of up to 50 pounds. Occasional assistance in building new site and site expansion activities which may consist of racking mounting gears. &nbsp;<br>• Must be able to move between buildings and floors. &nbsp;&nbsp;<br>• Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. &nbsp; &nbsp;<br>• Must be able to read, prepare emails, and produce documents and spreadsheets. &nbsp; &nbsp;&nbsp;<br>• Must be able to move within the office and access file cabinets or supplies, as needed. &nbsp;&nbsp;<br>• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis. &nbsp;</p>
<p><span style="text-decoration: underline;"><strong>Starting Base Salary is $120,000 to $175,000 &nbsp;</strong></span><br>We offer a competitive compensation package plus a benefits and equity program, when applicable. &nbsp;<br>Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.</p>
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Network Operations Engineer

<div><strong>General Summary</strong></div>
<div><br>The Equipment Technician I is responsible for the set up and maintenance of Penumbra’s manufacturing and test equipment as well as the necessary documentation in accordance with&nbsp; Penumbra’s Quality System.</div>
<div><br><strong>Specific Duties and Responsibilities&nbsp;</strong></div>
<div><br>• Perform and document maintenance activities, including preventative maintenance, ondemand maintenance, and non-standard repairs while following quality system procedures *<br>• Collaborate with other technicians: assisting other technicians with performing ondemand maintenance and troubleshooting as needed. *<br>• Perform on-demand maintenance and troubleshooting *<br>• Equipment installation and validation: Install equipment and complete validation processes such as IQ/OQ (Installation Qualification/Operational Qualification) to ensure proper functionality. *<br>• Utilize the spare parts system to maintain accurate inventory levels *&nbsp;<br>• With the guidance of senior level technicians, assist in solving equipment-related manufacturing problems. *&nbsp;<br>• With the guidance of senior level technicians and engineers, assist in solving equipmentrelated manufacturing problems. *&nbsp;<br>• Assemble equipment and fixtures in accordance with documented prints *<br>• Weekly overtime required as needed, including potential weekends, as permitted by law*<br>• Participate in manufacturing line moves and equipment relocation*<br>• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *&nbsp;<br>• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *&nbsp;<br>• Ensure other members of the department follow the QMS, regulations, standards, and procedures. *&nbsp;<br>• Perform other work-related duties as assigned.</div>
<div><br>*Indicates an essential function of the role<br><br><strong>Position Qualifications</strong></div>
<div><br>Minimum education and experience:<br>• High school diploma or GED with 1+ years of experience working in a medical device or&nbsp;<br>in a manufacturing environment, or equivalent combination of education and experience.</div>
<div>&nbsp;</div>
<div>Additional qualifications:&nbsp;<br>• Background in medical device, pharmaceutical, biotech, or other regulated industry experience desired<br>• Strong oral, written and interpersonal communication skills<br>• High degree of accuracy and attention to detail<br>• Proficiency with Outlook, MS Word, Excel, and PowerPoint<br>• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously</div>
<div><br>Working Conditions<br>• General office, laboratory, and cleanroom environments&nbsp;<br>• Willingness and ability to work on site.<br>• Potential exposure to blood-borne pathogens<br>• Requires some lifting and moving of up to 50 pounds, and occasionally up to 100 pounds with assistance. Requires occasional climbing on ladders up to 12 feet.<br>• Must be able to move between buildings and floors.<br>• Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.<br>• Must be able to read, prepare emails, and produce documents and spreadsheets.&nbsp;<br>• Must be able to move within the office and access file cabinets or supplies, as needed.<br>• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis</div>
<div>&nbsp;</div>
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<div><strong style="font-size: 10pt;">Base Pay Range Per Hour:&nbsp; $24.00 – 35.00</strong></div>
<div><span style="font-size: 10pt;">Individual compensation will vary based on factors such as qualifications, skill level, competencies, work location and shift, and will increase over time based on meeting performance and business needs.</span></div>
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Equipment Tech I

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<p><strong>General Summary</strong><br>The Therapy Development Specialist is a field-based role responsible for supporting therapy awareness, program development, and care pathway optimization across assigned hospital accounts. This position partners with physicians, nursing leaders, administrators, and internal cross-functional teams to identify opportunities, strengthen coordination of care, and support adoption of therapy solutions for patients with venous thromboembolism (VTE), including pulmonary embolism and deep vein thrombosis.<br>&nbsp;<br>The Therapy Development Specialist serves as a strategic partner to both internal and external stakeholders by helping to advance clinical and operational initiatives within targeted health systems. This role is focused on account engagement, education, and program development, and is not intended to function as a routine procedural support or case coverage role.</p>
<p><br><strong>Specific Duties and Responsibilities</strong><br>• Act as a regional VTE care path expert, driving improved care path knowledge across the regional teams you support while supporting a broad coalition of customers. These may include treating and managing physicians, administration, staff, and other personnel to drive VTE program optimization by acting as a liaison between Penumbra (PEN) and all key stakeholders. Must be able to prioritize key account work across multiple regions. *<br>• Develop and execute education and clinical care path strategies, drive (or support) clinical program development plans through innovative field education programs. *<br>• Manage account education initiatives throughout the project lifecycle and effectively communicate with regional sales team throughout.<br>• Identify and develop care path KOL’s and educational resources to leverage.<br>• Identify, organize, and execute local/regional care path tradeshows &amp; conferences and other meetings to optimize product and therapy awareness regionally. *<br>• Represent marketing as a key point of contact within a defined Sales region. *<br>• Work closely with field sales leaders, sales, and clinical teams.<br>• Be the regional expert in clinical data related to thrombectomy and stay current with product and therapy data and Penumbra collateral to incorporate messaging for raising therapy awareness. *<br>• Assist with local PR initiatives related to the launch of products working with hospital marketing, Penumbra product marketing, and Penumbra communications team to drive therapy awareness in the local market. *<br>• Drive understanding of patient &amp; clinician insights within the therapy, including patient and care path physician behavior. *<br>• Establish and foster relationships with key customers and key opinion leaders within assigned region to enable podium representation of Penumbra products and to ensure that launches and programs are relevant to drive understanding and adoption of related products.<br>• Assist in anticipating and responding to the needs of customers.<br>• Ability to utilize analytic methods to capture and evaluate regional activities, including analysis and recommendation of new opportunities, and adapt new processes and strategies, as necessary.<br>• Promote and maintain the Penumbra brand-raising therapy awareness within the assigned region.<br>• Collect and share intelligence with managers on relevant competitive products, activities, and/or therapies for competitive products.<br>• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *<br>• Understand relevant security, privacy, and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *<br>• Ensure other members of the department follow the QMS, regulations, standards, and procedures. *<br>• Perform other work-related duties as assigned.<br>*Indicates an essential function of the role</p>
<p><br><strong>Position Qualifications:</strong><br><strong>Minimum Education and Experience:</strong><br>• Bachelor’s degree required in nursing, healthcare, life sciences, business, marketing, or a related field with 5+ years of relevant experience in healthcare, medical device, clinical program development, hospital leadership, downstream marketing, or a related field-based role required.</p>
<p><strong>Additional Qualifications:</strong><br>• Demonstrated experience in hospital-based program development, quality improvement, care pathway optimization, service line development, or stakeholder engagement preferred<br>• Experience in VTE (Venous Thromboembolism), PE (Pulmonary Embolism), DVT (Deep Vein Thrombosis), cardiovascular services, critical care, emergency medicine, interventional services, or related acute care settings preferred<br>• Proven ability to work effectively with multidisciplinary hospital teams, including physicians, nursing leadership, quality leaders, and administrative stakeholders<br>• Strong understanding of hospital systems, clinical workflows, and the complexities of care pathway development preferred<br>• Strong organizational, project management, and prioritization skills, with the ability to manage multiple initiatives across a broad geography<br>• Demonstrated ability to work independently while collaborating effectively across internal and external teams<br>• Strong analytical, problem-solving, and strategic thinking capabilities<br>• Ability to adapt to evolving business needs and customer priorities<br>• Solid organizational skills and the ability to routinely work on multiple tasks with multiple people while effectively prioritizing work in an environment of often competing priorities<br>• Excellent interpersonal, communication, and negotiation skills for a wide variety of audiences, including sales &amp; marketing leadership, and the ability to develop strong relationships with internal and external customers and marketing partners</p>
<p><br><strong>Working Conditions</strong><br>• Field-based, remote position requiring frequent travel throughout assigned territory and other business locations as needed<br>• Business travel from 80% or more (US), with overnight stays 50%-75% of the time. Ability to travel extensively by car and plane<br>• Willingness and ability to conduct company business outside of the typical Monday through Friday, 8:00am to 5:00pm, work schedule including early mornings, evenings, and occasional weekends, in support of customer and business needs<br>• Requires some lifting and moving of up to 20 pounds<br>• Potential exposure to blood-borne pathogens, infectious disease, and radiation<br>• Must be able to work in Cath Labs or ORs with radiation exposure. Wear a lead apron for long periods of time (2-3hrs on average). Must be able to wear all required personal protective equipment (PPE)<br>• Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day<br>• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis</p>
<p><br><strong>Annual Base Salary Range: $110,000 to $175,000</strong><br>This is the pay range for a mid-cost labor market. If hired in another region, there will be a difference in pay range. We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.</p>
</div>

Therapy Development Specialist - Northeast Region

Industrial Engineer II

<div>
<p><strong>General Summary</strong><br>The temporary Clinical Data Manager acts as a lead data manager for one or more projects, applies data management experience to clinical trials, and utilizes functional knowledge of the logistics of clinical trials to ensure the quality and integrity of clinical trial data. The CDM works on multi-functional teams and supports clinical trial projects as a departmental subject matter expert (SME).</p>
<p>We are seeking a temporary clinical data manager who can dedicate 20 hours a week to support ongoing study activities. The initial assignment is for 6 months, but may be extended to meet the needs of our Team. Applicants must be eligible to live and work in the US.</p>
<p><br><strong>Specific Duties and Responsibilities</strong><br>•Independently lead and/or perform all data management activities within an assigned study (e.g., study startup, study conduct, study closeout, and reporting). *<br>•Serve as the data management SME on multidisciplinary project teams providing specific expertise on timeline development, identification of data management deliverables and resource requirements. *<br>•Participate in the creation, review, and maintenance of project timelines and monitor progress of data management activities. *<br>•Provide oversight for Data Management CRO and other vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, SOPs, and other relevant guidelines.<br>•Ensure Data Management documentation is filed/archived according to applicable Penumbra and regulatory requirements. *<br>•Interact with data management, biostatistics, Clinical Affairs and Medical Affairs team to ensure integrity and quality of data. *<br>•Contribute ideas to the development of the department, identifying areas for improvement (e.g., SOPs, processes)<br>•Participates in audits and inspections. *<br>•Attend Investigator Meetings when requested to provide training on CRF data completion.<br>•Responsible for creation of training materials and training of the CRAs to ensure consistency of data entry at the sites. *<br>•Provide DM departmental training and to other teams, as needed.<br>•Utilizes reports to track study progress and ensure timeliness and quality expectations are met.<br>•Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. *<br>•Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. *<br>•Ensure other members of the department follow the QMS, regulations, standards, and procedures. *<br>•Perform other work-related duties as assigned.<br><em>*Indicates an essential function of the role</em></p>
<p><br><strong>Required Qualifications</strong><br><strong>Minimum education and experience</strong><br>•Bachelor's degree with 5+ years in a medical device, pharmaceutical company, or similar environment (e.g., CRO); or an equivalent combination of education and experience</p>
<p><strong>Preferred qualifications</strong><br>•Master’s degree with 3+ years of clinical research, pharmaceutical company preferred<br>•Thorough knowledge of effective clinical data management practices; CCDM certified professional a plus<br>•Must have strong experience with systems used for electronic capture of clinical trial data (e.g., iMedidata Rave, InForm, eClinicalOS, RedCap)<br>•This position must have experience working on regulatory trials within the medical device and/or pharmaceutical industry<br>•Position requires technical, organizational, analytical, and strong communication skills<br>•Knowledge of regulatory guidelines pertaining to data quality and data management<br>•Proven experience and in-depth understanding of all aspects of Data Management<br>•Ability to effectively manage change and multiple priorities<br>•Ability to operate independently and achieve results; ability to effectively deal with employees and business contacts and conveys a positive service-oriented attitude<br>•Knowledge of continuous improvement, project management, change management, and risk management<br>•Medical device, pharmaceutical, biotech, or other regulated industry experience required<br>•Proficiency with MS Word, Excel, and PowerPoint</p>
<p>&nbsp;</p>
<p><strong>Working Conditions</strong><br>•General office environment<br>•Willingness and ability to work on site.<br>•May have business travel from 0% - 5% to conferences and/or other Penumbra affiliated facilities.<br>•Potential exposure to blood-borne pathogens<br>•Requires some lifting and moving of up to 25 pounds<br>•Must be able to move between buildings and floors.<br>•Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.<br>•Must be able to read, prepare emails, and produce documents and spreadsheets.<br>•Must be able to move within the office and access file cabinets or supplies, as needed.<br>•Must be able to communicate and exchange accurate information with employees at all levels on a daily basis. Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.</p>
<p>&nbsp;</p>
<p><strong>Base Pay Range Per Hour: $50.00 - $80.00</strong><br>Individual compensation will vary based on factors such as qualifications, skill level, competencies, and work location.</p>
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Clinical Data Manager (Temporary Position, 20 hours/week)

Sr. SAP Basis Administrator

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<strong>General Summary&nbsp;</strong></div>
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<div data-ccp-timestamp="1792100567554">The Equipment Technician II is responsible for the set up and maintenance of Penumbra’s manufacturing and test equipment as well as the necessary documentation in accordance with Penumbra’s Quality System. &nbsp;</div>
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<div data-ccp-timestamp="1792100567554"><strong>Specific Duties and Responsibilities </strong></div>
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<div data-ccp-timestamp="1792100567554">• Manage and perform maintenance activities including preventative maintenance, ondemand maintenance, and non-standard repairs while documenting activities by following quality system procedures. * &nbsp;</div>
<div data-ccp-timestamp="1792100567554">• Assist other technicians with performing on-demand maintenance and troubleshooting as needed. *</div>
<div data-ccp-timestamp="1792100567554">• Equipment installation and validation: Install equipment and complete validation processes such as IQ/OQ (Installation Qualification/Operational Qualification) to ensure proper functionality. * &nbsp;</div>
<div data-ccp-timestamp="1792100567554">• Spare parts management: Utilize the spare parts system to maintain accurate inventory levels, track usage, and reorder parts when necessary. *</div>
<div data-ccp-timestamp="1792100567554">• With the guidance of senior level technicians and engineers, assist in solving equipmentrelated manufacturing problems. * &nbsp;</div>
<div data-ccp-timestamp="1792100567554">• Assemble equipment and fixtures in accordance with documented prints. * &nbsp;</div>
<div data-ccp-timestamp="1792100567554">• Improve equipment documentation by suggesting revisions to Equipment Binders and preventative maintenance instructions for new and existing equipment. &nbsp;</div>
<div data-ccp-timestamp="1792100567554">• Procure equipment and fixtures to support manufacturing. &nbsp;</div>
<div data-ccp-timestamp="1792100567554">• Make suggestions regarding equipment and fixtures that may improve throughput, yield, and/or ergonomics.</div>
<div data-ccp-timestamp="1792100567554">• Solve practical problems encountered. *</div>
<div data-ccp-timestamp="1792100567554">• Train junior equipment technicians on simple equipment repairs and departmental practices. &nbsp;</div>
<div data-ccp-timestamp="1792100567554">• Weekly overtime required as needed, including potential weekends, as permitted by law *</div>
<div data-ccp-timestamp="1792100567554">• Participate in manufacturing line moves and equipment relocation*&nbsp;</div>
<div data-ccp-timestamp="1792100567554">• Adhere to the Company’s Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures. * &nbsp;</div>
<div data-ccp-timestamp="1792100567554">• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company. * &nbsp;</div>
<div data-ccp-timestamp="1792100567554">• Ensure other members of the department follow the QMS, regulations, standards, and procedures. * &nbsp;</div>
<div data-ccp-timestamp="1792100567554">• Perform other work-related duties as assigned.</div>
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<div data-ccp-timestamp="1792100567554">*Indicates an essential function of the role &nbsp;</div>
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<div data-ccp-timestamp="1792100567554"><strong>Position Qualifications </strong></div>
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<div data-ccp-timestamp="1792100567554">Minimum education and experience: &nbsp;</div>
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<div data-ccp-timestamp="1792100567554">• High school diploma or GED with 3+ years of experience working in a medical device or in a manufacturing environment, or an equivalent combination of education and experience. &nbsp;</div>
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<div data-ccp-timestamp="1792100567554">Additional qualifications: &nbsp; &nbsp; &nbsp;</div>
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<div data-ccp-timestamp="1792100567554">• Proven ability to build, troubleshoot, repair and maintain manufacturing equipment per GMP guidelines, preferably in the medical device industry. &nbsp;</div>
<div data-ccp-timestamp="1792100567554">• Medical device, pharmaceutical, biotech, or other regulated industry experience desired</div>
<div data-ccp-timestamp="1792100567554">• Strong oral, written and interpersonal communication skills</div>
<div data-ccp-timestamp="1792100567554">• High degree of accuracy and attention to detail</div>
<div data-ccp-timestamp="1792100567554">• Proficiency with Outlook, MS Word, Excel, and PowerPoint</div>
<div data-ccp-timestamp="1792100567554">• Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously</div>
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<div data-ccp-timestamp="1792100567554">Working Conditions &nbsp;</div>
<div data-ccp-timestamp="1792100567554">• General office, laboratory, and cleanroom environments &nbsp;</div>
<div data-ccp-timestamp="1792100567554">• Willingness and ability to work on site.</div>
<div data-ccp-timestamp="1792100567554">• Potential exposure to blood-borne pathogens</div>
<div data-ccp-timestamp="1792100567554">• Requires some lifting and moving of up to 50 pounds, and occasionally up to 100 pounds with assistance. Requires occasional climbing on ladders up to 12 feet.</div>
<div data-ccp-timestamp="1792100567554">• Must be able to move between buildings and floors. &nbsp;</div>
<div data-ccp-timestamp="1792100567554">• Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day. &nbsp;</div>
<div data-ccp-timestamp="1792100567554">• Must be able to read, prepare emails, and produce documents and spreadsheets. &nbsp; &nbsp;</div>
<div data-ccp-timestamp="1792100567554">• Must be able to move within the office and access file cabinets or supplies, as needed. &nbsp;</div>
<div data-ccp-timestamp="1792100567554">• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis. Signature page to follow.&nbsp;</div>
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<div data-ccp-timestamp="1792100567554">The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.&nbsp;</div>
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<p style="margin: 0in; font-size: 11pt; font-family: Calibri, sans-serif;"><strong><span style="font-size: 10.0pt; font-family: Arial, sans-serif;">Base Pay Range Per Hour:&nbsp; </span></strong><strong><span style="font-size: 10.0pt; font-family: Arial, sans-serif;">$30.00 – 41.00</span></strong></p>
<p style="margin: 0in; font-size: 11pt; font-family: Calibri, sans-serif;"><span style="font-size: 10.0pt; font-family: Arial, sans-serif;">Individual compensation will vary based on factors such as qualifications, skill level, competencies, work location and shift, and will increase over time based on meeting performance and business needs.</span></p>
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