Design Verification Engineer Saint-Antoine-sur-Richelieu

Position: Design Verification Engineer - InfoStride (Saint-Antoine-sur-Richelieu)
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 compliance with regulatory standards
Required Skills & Experience   10+ years in reliability engineering (product / hardware / Med Tech)
Robust 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)

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