Found Description
About the Role
We are seeking a Senior Reliability Engineer with strong experience in medical device / IVD product development. The role focuses on designing and executing reliability strategies for regulated hardware products across R&D, quality, and manufacturing environments.
Key Responsibilities
- Develop and implement reliability requirements and test strategies for IVD medical devices
- Lead DFMEA / PFMEA and reliability risk assessments
- Design and execute HALT, HASS, ALT, and lifecycle testing programs
- Perform life data analysis (Weibull, lognormal, survival models)
- Develop test methods, fixtures, and design verification protocols
- Conduct root cause analysis and manage FRACAS activities
- Analyze test data and prepare technical reports for stakeholders
- Collaborate with R&D, QA, and manufacturing teams to ensure Design for Reliability (DFR)
- Support design reviews and ensure compl...
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