Job Description
Exp range: 4+ years in Product/core reliability engineering (Avoid quality / site/asset reliability engineer profiles)
Keywords to look in a profile:
Prioritize candidates with medical device or regulated hardware experience, strong background in reliability engineering, HALT/HASS/ALT, and statistical modeling (Weibull, lognormal).
Technical Evaluation – Assess expertise in DFMEA/PFMEA, fault tree analysis, accelerated life testing, DOE, and use of data tools (Minitab/JMP required; Python/Matlab/R preferred).
Regulatory Knowledge – Verify familiarity with ISO 13485, ISO 14971, FDA 21 CFR 820, EU MDR/IVDR, IEC 60601, IEC 62304, IEC 62366‑1, ISO 10993, and ISO 17025.
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Keywords to look in a profile:
Prioritize candidates with medical device or regulated hardware experience, strong background in reliability engineering, HALT/HASS/ALT, and statistical modeling (Weibull, lognormal).
Technical Evaluation – Assess expertise in DFMEA/PFMEA, fault tree analysis, accelerated life testing, DOE, and use of data tools (Minitab/JMP required; Python/Matlab/R preferred).
Regulatory Knowledge – Verify familiarity with ISO 13485, ISO 14971, FDA 21 CFR 820, EU MDR/IVDR, IEC 60601, IEC 62304, IEC 62366‑1, ISO 10993, and ISO 17025.
#J-18808-Ljbffr