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