Medical Device Engineering
Reliability Engineer
Lead reliability engineering for regulated diagnostic products through DFR, reliability test plans, fixtures, FMEA, statistics, and risk reduction.
Role overview
Role overview
Serve as reliability engineering subject matter expert for regulated medical and diagnostic product development and production support.
Responsibilities
- Develop reliability requirements, plans, test methods, fixtures, protocols, and final reports.
- Lead DFMEA, DFR practices, reliability testing, environmental testing, lifecycle testing, and accelerated aging work.
- Analyze failures, perform root-cause investigations, maintain FRACAS data, and recommend reliability improvements.
- Work with R&D, QA, manufacturing, and project teams on reliability goals and risk reduction.
- Use statistical methods, life data analysis, and process-control data to support reliability decisions.
Requirements
- Mechanical, electrical, reliability engineering, or related background.
- Regulated industry experience, preferably medical device.
- Knowledge of ISO 13485, 21 CFR 820, IEC 61010, IEC 60601, IEC 62506, IEEE 1413, IEEE 1332, Reliasoft, PTC Windchill, and Minitab.
Skills and signals
Reliability engineeringDFRDFMEAFRACASISO 1348521 CFR 820MinitabReliasoft