As a Reliability Engineer, you will ensure our medical devices meet or exceed product reliability, safety, and quality requirements throughout the product lifecycle —from concept and design through verification, validation, launch, and post‑market. You will define reliability targets and models , architect test strategies (ALT/HALT/HASS/ORT) , execute root‑cause analysis , and drive corrective/preventive actions with R&D, Manufacturing/Operations, Quality/Regulatory, and Suppliers/CMs. Your work directly supports regulatory compliance (FDA/EU IVDR) and patient safety . 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. 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 . Demonstrated Expertise in Reliability statistics (Weibull/parametric life data analysis, confidence bounds, reliability growth). DfR and FMEA (DFMEA/PFMEA) , fault tree analysis, and risk management per ISO 14971 . HALT/HASS/ALT , environmental & stress testing, sample size justification, and DOE . Data tools : Minitab/JMP (required); Python/Matlab/R is a plus. Strong understanding of QMS and regulatory frameworks : ISO 13485 , 21 CFR 820/21 CFR 820.3 (QMSR) alignment, EU MDR , IEC 60601 , IEC 62304 , IEC 62366‑1 , ISO 10993 , ISO 17025 testing principles. Proven track record translating field/customer feedback into design/process changes and sustaining engineering improvements . #J-18808-Ljbffr