Design Verification Engineer - richmond hill
Infostride
Reliability Engineer (MedTech / IVD)
Location: Ottawa, Ontario, Canada
Experience: 10+ years in product/core reliability engineering (MedTech only)
About the Role
We are seeking a Senior Reliability Engineer with solid 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 compliance with regulatory standards
Required Skills & Experience
- 10+ years in reliability engineering (product / hardware / MedTech)
- Strong experience in DFMEA, FTA, HALT/HASS/ALT, DOE
- Expertise in life data analysis (Weibull, lognormal)
- Hands‑on experience with Minitab and/or JMP (required)
- Familiarity with Python / MATLAB / R (preferred)
- Experience designing custom test fixtures and validation setups
- Strong knowledge of regulated standards: ISO 13485, ISO 14971, FDA 21 CFR 820, IEC 60601, IEC 62304, IEC 62366‑1, EU MDR / IVDR
- Experience in medical device or IVD industry (mandatory)
Vacancy posted 8 days ago
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