Job Description
Verification/Validation & Compliance
- Verification/Validation & Compliance
Manufacturing & Supplier/CM Interface
- Manufacturing & Supplier/CM Interface
Key Responsibilities
- Reliability Planning & Targets
- Translate user needs, clinical risks, and business goals into reliability requirements (e.g., MTTF/MTBF, mission profiles, wear‑out models).
- Develop Reliability Plans aligned to Design & Development phases and risk controls (ISO 14971).
- Design for Reliability (DfR)
- Partner with Systems, Electrical, Mechanical, and Software teams to design‑in reliability (materials selection, derating, thermal/mechanical margining, design rules).
- Lead DFMEA/PFMEA and ensure risk controls flow into design verification and process validation strategies.
- Reliability Modeling & Data Analytics
- Build and maintain reliability models (e.g., Weibull, exponen...