Senior Design Quality Engineer, New Product Development Advanced
Core
Senior Design Quality Engineer ensuring surgical device quality from concept to commercialization, driving patient safety and surgical efficiency.
Role type
Senior Design Quality Engineer (Medical Devices)
Builds
Surgical lights, tables, and booms for operating rooms
Domain
Medical Devices / Healthcare
Required skills
Risk management, Design verification & validation (V&V), Regulatory compliance, Statistical analysis, Manufacturing process development, Design transfer oversight, Mentorship
Preferred skills
Design Quality Engineering, NPD with medical devices, Risk/benefit analysis, FDA/regulatory body interaction, Reliability testing
Technologies
None explicitly stated
Responsibilities
Partner with R&D to define design requirements and develop manufacturing processes; Lead risk management activities and design reviews; Drive design verification, validation, and user testing; Prepare quality documentation for regulatory submissions; Conduct risk/benefit analyses for executive leadership; Oversee design transfers to manufacturing sites; Mentor junior engineers
Seniority
Senior, hands-on IC