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 (Medical Devices)
Builds
Medical device products ensuring compliance with quality and safety standards
Domain
Healthcare / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
FMEA, Product Safety Risk Management, IEC 62304, IEC 62366, 21CFR820, Design Input Oversight, Design V&V, Design Transfer, Post-market Quality Analysis
Preferred skills
IEC 14971, Usability Engineering, Medical Device Software Life Cycle
Technologies
IEC 62304, IEC 62366, 21CFR820, IEC 14971
Responsibilities
Accountable for oversight of system and hardware quality and safety risk management throughout the product life cycle; Provide independent oversight of design input, V&V, design transfer, and product realization; Act as single point of contact to ensure hardware design meets quality and compliance standards; Perform independent technical assessment on product quality performance and post-market product quality analysis
Seniority
Senior, hands-on IC