Design Verification Engineer

Reliability Engineer (Med Tech / IVD)

Location:

Ottawa, Ontario, Canada

Experience:

10+ years in product/core reliability engineering (Med Tech only)

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.

• 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

• 10+ years in reliability engineering (product / hardware / Med Tech)
• 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)