Sr. Design Assurance Engineer

Senior Design Assurance Engineer

Our client, a growing medical device company, is adding a Senior Design Assurance Engineer to play a key role in the development and commercialization of an innovative device.

This is an opportunity to work on a complex Class III implantable device as the company advances toward significant regulatory and commercialization milestones, including PMA and CE Mark approval.

The Senior Design Assurance Engineer will work at the intersection of R&D, Quality, Regulatory, Clinical, and Operations, with significant ownership of design controls, risk management, technical documentation, and Design History File (DHF) activities.

This role is ideal for someone who enjoys being close to product development and wants the visibility and breadth of responsibility that comes with working in a smaller, fast-paced medical device organization, and someone who wants to be close to the technology and involved in more than one narrow piece of Design Assurance.

• Lead design assurance activities throughout the product lifecycle, from new product development through commercialization.
• Own and support design control activities, including design inputs and outputs, design reviews, verification and validation, and design transfer.
• Lead the development and maintenance of Design History Files (DHF), ensuring documentation is accurate, traceable, complete, and audit-ready.
• Author and review risk management documentation in accordance with ISO 14971, including risk analyses, FMEAs, risk management plans, and reports.
• Evaluate new and revised industry standards, identify compliance gaps, and drive remediation activities.
• Author and review technical documentation supporting regulatory submissions, including protocols, reports, and risk documentation.
• Partner cross-functionally with R&D, Clinical, Operations, Regulatory Affairs, and Quality to ensure design and development activities meet applicable requirements.
• Support FDA, notified body, and internal audits and inspections, particularly those involving design and development documentation.
• Support manufacturing process and equipment qualification activities, including IQ, OQ, and PQ.
• Identify and drive continuous improvement opportunities across design assurance, quality systems, and product development processes.
• Mentor junior engineers and provide technical leadership across projects and cross-functional initiatives.

• Bachelor's degree in Engineering, Life Sciences, or another technical discipline, or equivalent experience.
• 5+ years of medical device experience within design assurance, product development, or quality engineering.
• Working knowledge of FDA QMSR/21 CFR Part 820, ISO 13485, ISO 14971, and EU MDR requirements.
• Demonstrated experience with design controls, risk management, design documentation, and/or Design History Files.
• Experience with Nitinol processing, including forming, heat treatment, electropolishing, or surface finishing a huge plus.
• Knowledge of ISO 5840 and ISO 10993-1.
• Experience using statistical analysis tools such as Minitab.
• Ability to travel up to 10%