Senior Design Assurance Engineer

Senior Design Assurance Engineer

Location:

San Francisco, CA

Full-Time (on-site, 5 days/wk)

• Develop and maintain design & development files, medical device files, and design control documentation per ISO 13485:2016 and 21 CFR Part 820 (QMSR).
• Work closely with the engineering team to author and review design inputs, design outputs, verification and validation protocols and reports.
• Interpret and apply applicable standards and regulations to develop verification testing plans and establish acceptance criteria.
• Facilitate and document design reviews, ensuring compliance and end-to-end traceability from user needs and requirements through verified design outputs.
• Lead product risk management activities in accordance with ISO 14971, including hazard identification, FMEAs, risk-benefit analysis, residual risk evaluation, etc.
• Support maintenance of the QMS, including supplier qualification, change control, document management, etc.
• Support the preparation of IDE and PMA submission packages

• B.S. in Biomedical, Electrical, Mechanical Engineering, or related engineering discipline. Advanced degree preferred.
• 4+ years of overall experience in the medical device industry, including at least 2 years in a design assurance, quality engineering, or R&D quality role.
• Working knowledge of medical device design controls, quality system regulations, risk management, and electrical safety standards, including ISO 13485:2016, 21 CFR Part 820, ISO 14971, and IEC 60601-1.
• Experience supporting verification and validation activities for medical device hardware or electromechanical systems.
• Strong attention to detail, technical writing skills, and ability to work cross-functionally with engineering, quality, regulatory, external suppliers and R&D teams across multiple sites, including support for product development activities at our UK site.

• Design assurance experience with active implantable medical devices.
• Working knowledge of ISO 14708-1:2014.
• Experience supporting IDE applications, PMA submissions, or early feasibility clinical submissions.
• Experience in early-stage or startup environments.

This role is an integral part of the Product Development team and reports to Quality & Regulatory/VP of Engineering.

• US standard
• Healthcare, dental and vision
• 401k with company match
• Industry leading paid time off (PTO) - 20 days/year + holidays
• Meals and snacks provided
• Professional development support and training opportunities.
• Flexible working hours and travel opportunities (We have sites in Australia, UK and US!)
• A chance to work on impactful, life-changing technologies in a dynamic, innovative environment.