Senior Design Quality Engineer
Core
Oversees system and hardware quality and safety risk management throughout the product life cycle for medical devices.
Role type
Senior Design Quality Engineer
Builds
Medical device products ensuring compliance with quality and safety standards
Domain
Medical Devices / Hardware Engineering
Required skills
Risk management (IEC 14971), Medical Device Software Life Cycle (IEC 62304), Usability Engineering (IEC 62366), 21CFR820 compliance, FMEA, Design V&V, Design transfer oversight, Post-market quality analysis
Preferred skills
Mechanical or Electronics Engineering background, 5+ years in regulated environment, FMEA expertise
Technologies
IEC 14971, IEC 62304, IEC 62366, 21CFR820
Responsibilities
Accountable for oversight of system and hardware quality and safety risk management; Provide independent oversight of design input, V&V, design transfer, and product realization; Act as single point of contact for hardware design quality and compliance; Perform independent technical assessment on product quality performance and post-market analysis
Seniority
Senior, hands-on IC