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, exponential, lognormal), reliability growth (Duane/AMSAA),...