Reliability Engineer

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.

Responsibilities

• Working with R&D, quality assurance and manufacturing teams to develop reliability requirements (including requirements cascade), develop and implement comprehensive reliability test plans for IVD medical devices that align with product development and production processes.
• Developing reliability plans and requirements, leading and facilitating Design Failure Mode and Effects ...