Medical Device Reliability Engineer

We are hiring a  Senior Reliability Engineer  with  10+ years of experience in the Medical Device/Med Tech industry (MANDATORY) . Candidates must have a strong background in core reliability engineering for regulated hardware products, preferably IVD devices.

Must-Have

Skills:

Medical Device/Med Tech 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:

Python, MATLAB, or R

Only candidates with prior  Medical Device/Med Tech experience  will be considered. Profiles from Quality Engineering, Site Reliability Engineering (SRE), Asset Reliability, or non‑medical domains will not be considered.

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