Job Description
Keywords to look in a profile
- Prioritize candidates with medical device or regulated hardware experience, strong background in reliability engineering, HALT/HASS/ALT, and statistical modeling (Weibull, lognormal).
- Technical Evaluation Assess expertise in DFMEA/PFMEA, fault tree analysis, accelerated life testing, DOE, and use of data tools (Minitab/JMP required; Python/Matlab/R preferred).
- Regulatory Knowledge Verify familiarity with ISO 13485, ISO 14971, FDA 21 CFR 820, EU MDR/IVDR, IEC 60601, IEC 62304, IEC 62366 1, ISO 10993, and ISO 17025.
Overview
Responsibilities
- Additional responsibilities for this position are as follows:
- Working with R&D, quality assurance and manufacturing teams to develop reliability requirements (including requirements cascade), develop and implement comprehensive reliability test plans for IVD medical devices that align with product develop...