Found Description
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...
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