Senior (Quality Engineer 4) - Multiport Da Vinci Systems
Core
Quality functional leader supporting the development of next-generation surgical systems (cameras, instruments, accessories) from concept through commercialization.
Role type
Senior Quality Engineer (Medical Devices)
Builds
Next-generation robotic surgical systems and accessories
Domain
Medical Devices / Robotic Surgery
Required skills
Design controls, risk management, process validation, design for reliability, regulatory compliance (FDA/ISO), supplier qualification, technical reviews
Preferred skills
Reliability principles, limit/challenge testing, V&V execution
Technologies
ISO 14971, IEC 60601, IEC 62304, ISO 80002-1, FDA Design Controls
Responsibilities
Contribute to planning and execution of design controls and risk management; Ensure reliable designs are transferred to manufacturing; Support regulatory submissions and audits; Partner with engineering to define design inputs/outputs and traceability matrices; Assist in supplier selection and qualification.
Seniority
Senior, hands-on IC
