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