Medtech Reliability Engineer Opportunity Hamilton
Infostride
Join a leading team as a MedTech Reliability Engineer in Ottawa, Ontario. This senior role demands expertise in reliability strategies for IVD device development and emphasizes hands‑on testing and analysis. You will lead efforts in reliability engineering with a minimum of 10 years in the field. Key responsibilities include implementing test strategies, developing custom test fixtures, and performing risk assessments. You’ll collaborate closely with R&D; and QA to uphold regulatory compliance while supporting design reviews.
Experience in the IVD industry is vital for enhancing product dependability and regulatory compliance.
Key Responsibilities
- Implement reliability requirements and testing strategies
- Lead DFMEA and risk assessments for product reliability
- Execute and analyze HALT, HASS, and ALT tests
- Perform life data analysis using Weibull and lognormal techniques
- Conduct root cause analyses and support FRACAS activities
Requirements
- Over 10 years of experience in MedTech reliability engineering
- Expertise in HALT/HASS/ALT and DFMEA
- Proficient user of Minitab or JMP
- Familiarity with Python or MATLAB preferred
- Solid understanding of ISO and FDA standards
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