Medical Device Reliability Engineer

We are hiring a Senior Reliability Engineer with 10+ years of experience in the Medical Device/MedTech industry (MANDATORY) . Candidates must have a strong background in core reliability engineering for regulated hardware products, preferably IVD devices. Must-Have Skills: Medical Device/MedTech experience is mandatory 10+ years of core Reliability Engineering experience Design for Reliability (DFR) HALT, HASS, ALT, accelerated life testing DFMEA, PFMEA, Fault Tree Analysis (FTA), FRACAS Weibull analysis and life data analysis DOE, verification testing, and custom test fixture development Hands-on experience with Minitab and/or JMP Knowledge of ISO 13485, ISO 14971, FDA 21 CFR 820 , and related medical device standards Preferred: IVD (In Vitro Diagnostics) experience ReliaSoft/PTC Windchill experience Python, MATLAB, or R Note: Only candidates with prior Medical Device/MedTech experience will be considered.

Profiles from Quality Engineering, Site Reliability Engineering (SRE), Asset Reliability, or non-medical domains will not be considered.