Senior Design Assurance Engineer
Summary
Senior Design Assurance Engineer at a medical device company developing a transcatheter mitral valve replacement system. Leads design controls, risk management per ISO 14971, Design History File activities, verification/validation, and regulatory documentation supporting FDA PMA and CE Mark submissions.
WHO WE ARE
We are a growing medical device company developing innovative technology to transform the treatment of mitral valve disease. Our team is advancing a transcatheter mitral valve replacement system through pivotal clinical development, with a shared commitment to bringing safe, effective, and innovative technology to patients.
THE OPPORTUNITY
We are seeking a Senior Design Assurance Engineer to play a key role in the design, development, and commercialization of our transcatheter mitral heart valve replacement. This role will be instrumental in ensuring our product development activities meet global quality and regulatory requirements while supporting critical milestones toward PMA and CE Mark approval.
This is an opportunity to work at the intersection of engineering, quality, regulatory, and product development, with significant ownership of design controls, risk management, technical documentation, and Design History File (DHF) activities.
HOW YOU WILL CONTRIBUTE
- Lead design assurance activities throughout the product lifecycle, from new product development through commercialization.
- Own and support design controls, including design inputs, outputs, design reviews, verification and validation, and design transfer.
- Lead 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.
- Lead assessments of new and revised standards, identify compliance gaps, and drive remediation activities.
- Author and review technical documentation supporting regulatory submissions, including protocols, reports, and risk documentation.
- Provide design assurance and quality engineering support to R&D, Clinical, Operations, and Regulatory Affairs.
- 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.
- Drive continuous improvement across design assurance, quality systems, and product development processes.
- Mentor junior engineers and provide leadership on projects and cross-functional initiatives.