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Reliability Engineer
Posted 3 days ago
About the role
- Reliability Engineer focusing on reliability engineering for medical devices. Collaborating on reliability test planning and development with regulatory compliance.
Responsibilities
- Prioritize candidates with medical device or regulated hardware experience, strong background in reliability engineering, HALT/HASS/ALT, and statistical modeling (Weibull, lognormal).
- Assess expertise in DFMEA/PFMEA, fault tree analysis, accelerated life testing, DOE, and use of data tools (Minitab/JMP required; Python/Matlab/R preferred).
- 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.
- Work 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 development and production processes.
- Develop reliability plans and requirements, leading and facilitating Design Failure Mode and Effects Analysis (DFMEA).
- Design and develop test methods and fixtures to assess the performance and durability of IVD devices.
- Write test protocols, train personnel on test procedures, analyze data and create final reports.
- Conduct reliability tests and document results including environmental, lifecycle, and accelerated aging tests, to evaluate product performance.
- Analyze test results and provide detailed reports, identifying areas for improvement and potential risks.
- Serve as the subject matter expert and technical representative for the reliability engineering function in project teams.
- Recommend design or test methods and statistical process control procedures for achieving required levels of product reliability.
- Lead and direct multiple projects in a fast-paced, cross-functional environment.
- Participate in design reviews and work with engineering to drive DFR (Design for Reliability) process.
Requirements
- Bachelor’s degree (Advanced degree preferred) in Mechanical /Electrical /Reliability Engineering or related discipline.
- 10+ years reliability engineering experience in highly regulated industry preferably in a medical device industry.
- Previous experience creating custom verification tests and fixtures.
- Previous experience planning verification tests (DoE, sample size selection, etc.)
- Experience in Reliability and statistical analysis software like Reliasoft/PTC Windchill/Minitab.
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