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), and usage profiles. Analyze field performance, complaint trends, ORT/line yield, and supplier/CM quality metrics to identify improvement levers. Accelerated & Environmental Testing Plan/execute Accelerated Life Tests (ALT), HALT/HASS, high‑stress screening, and environmental/transport profiles. Define sample sizes, censoring strategies, stopping rules, and acceptance criteria using sound statistical methods (JMP/Minitab). Verification/Validation & Compliance Align reliability evidence with DHF/DMR and regulatory submissions (e.g., 510(k)/PMA, EU MDR Technical File). Support IEC 60601 (safety), IEC 62304 (software), IEC 62366-1 (usability), and ISO 10993 (biocompatibility) touchpoints impacting reliability. Manufacturing & Supplier/CM Interface Define/oversee incoming, in‑process, and end‑of‑line reliability screens (e.g., ORT) and process capability (Cp/Cpk). Drive supplier quality improvements and cost‑out/VAVE without compromising reliability. Post‑Market Reliability Own the post‑market reliability surveillance plan: complaint analysis, trend detection, CAPA, and field corrective actions. Lead root‑cause analysis (5‑Whys, Ishikawa, Fault Tree) and implement containment, corrective, and preventive actions. Documentation & Communication Create clear plans, protocols, reports, and executive readouts; ensure traceability across URS/SRS ↔ Risk ↔ V&V. Required Qualifications Bachelor’s in Mechanical, Electrical, Biomedical, Systems, or related engineering; Master’s preferred. 5–8+ years of reliability/quality/test engineering experience in regulated hardware products; medical devices strongly preferred. #J-18808-Ljbffr