Reliability Engineer.

Title: Reliability Engineer Location: Ottawa, Ontario, Canada (Onsite) Visa: Canadian citizen / PR, Open Work Permit Experience: 4+ years in product/core reliability engineering (Medical device/MedTech domain only) Responsibilities Work with R&D, quality assurance, and manufacturing teams to develop reliability requirements and create comprehensive reliability test plans for IVD medical devices that align with product development and production processes. Lead and facilitate Design Failure Mode and Effects Analysis (DFMEA). Design and develop test methods and fixtures to assess the performance and durability of IVD devices.

Write test protocols, train personnel on test procedures, analyze data, and create final reports. Conduct reliability tests, including environmental, lifecycle, and accelerated aging tests, to evaluate product performance under different conditions and in compliance with regulatory standards. Analyze test results, provide detailed reports, and identify areas for improvement and potential risks.

Serve as the subject matter expert and technical representative for the reliability engineering function in project teams. Recommend design or test methods and statistical process control procedures to achieve required levels of product reliability. Lead and direct multiple projects in a fast‑paced, cross‑functional environment.

Participate in design reviews and work with engineering to drive the Design for Reliability (DFR) process and tools, supporting the definition and execution of reliability plans. Review device failures, perform root cause investigations, and document results in a failure reporting, analysis, and corrective action (FRACAS) system. Compile and analyze performance reports and process control statistics; investigate variables potentially affecting product and processes.

Qualifications Deep understanding of design for reliability and reliability engineering. Knowledge of regulations and best practices for medical device development such as ISO 13485 and 21 CFR 820, and familiarity with IEC 61010, IEC 60601, IEC 62304, IEC 62366, ISO 14971, ISO 10993, ISO 17025, and ISO 13485. Ability to generate data and perform life data analysis, including statistical modeling with Weibull, lognormal, Reliasoft, PTC Windchill, Minitab, JMP, Python, MATLAB, or R.

Experience building fixtures and conducting life data analysis for in‑vitro diagnostics medical products. Strong project management skills and ability to prioritize tasks effectively. Excellent communication skills for interacting with engineers, managers, and stakeholders.

Demonstrated ability to lead, motivate, and collaborate with technical teams and drive results. Proven problem‑solving skills related to design for reliability. Capability to analyze data, identify patterns, and develop solutions for potential problems.

Strong understanding of engineering principles and familiarity with relevant software and tools. Risk assessment skills to identify and evaluate risks that could delay project timelines or increase costs. Experience developing processes and methodology to model system and subsystem reliability.

Experience working with development teams to conduct effective FMEAs and reduce risk. Bachelor's degree (advanced degree preferred) in Mechanical, Electrical, Reliability Engineering or a related discipline. 10+ years of reliability engineering experience in highly regulated industries, preferably in the medical device sector. Previous experience creating custom verification tests and fixtures.

Previous experience planning verification tests, including DoE and sample size selection. Experience with reliability and statistical analysis software such as Reliasoft, PTC Windchill, and Minitab. #J-18808-Ljbffr