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:

Python, MATLAB, or R

Only candidates with prior

Medical Device/MedTech experience