We are partnering with a growing medical device company seeking a
Senior Design Assurance Quality Engineer to support product development from concept through launch.This is a highly visible, cross-functional role working closely with R&D, Quality, Regulatory, and Manufacturing teams to ensure products are developed in compliance with FDA and ISO standards—while maintaining a strong focus on quality, risk management, and timely product delivery.
What You’ll Be Doing- Lead and support Design Assurance activities across product development programs
- Ensure compliance with Design Controls and Risk Management requirements
- Drive Verification & Validation (V&V) planning, execution, and documentation
- Partner with cross-functional teams to ensure quality is built into product design
- Support risk management activities (FMEAs, hazard analysis, risk assessments)
- Contribute to design transfer and manufacturing readiness
- Maintain clear and compliant design documentation for regulatory submissions
- Support post-market activities, including investigations and data analysis
- Support software quality activities aligned with IEC 62304
What We’re Looking For- Bachelor’s degree in Engineering or related technical field
- 5–8+ years of experience in Design Assurance / Quality Engineering within medical devices or life sciences
- Strong knowledge of:
- FDA 21 CFR 820
- ISO 13485 and ISO 14971
- Hands-on experience with:
- Design Controls
- Verification & Validation (V&V)
- Risk Management (FMEA, hazard analysis)
- Experience supporting new product development and design transfer
- Strong communication skills and ability to work cross-functionally
Nice to Have:- Experience with software design assurance (IEC 62304)
- Familiarity with complex devices (electromechanical, catheter-based, etc.)
- Experience with statistical tools or data analysis