Description

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 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 / 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)