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

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