Reliability Engineer

This is a fully remote position, open to applicants in Canada.

📋 Description

• Seek candidates with expertise in medical devices or regulated hardware, along with a robust background in reliability engineering, HALT/HASS/ALT, and statistical modeling (Weibull, lognormal).

• Evaluate proficiency in DFMEA/PFMEA, fault tree analysis, accelerated life testing, DOE, and the use of data tools (Minitab/JMP required; Python/Matlab/R preferred).

• Confirm knowledge of ISO 13485, ISO 14971, FDA 21 CFR 820, EU MDR/IVDR, IEC 60601, IEC 62304, IEC 62366‑1, ISO 10993, and ISO 17025.

• Collaborate with R&D, quality assurance, and manufacturing teams to establish reliability requirements (including requirements cascade), and develop and implement comprehensive reliability test plans for IVD medical devices that are in line with product development and production processes.

• Formulate reliability plans and specifications, leading and facilitating Design Failure Mode and Effects Analysis (DFMEA).

• Create and develop testing methods and fixtures to evaluate the performance and durability of IVD devices.

• Draft test protocols, train staff on testing procedures, analyze data, and produce final reports.

• Execute reliability testing and document outcomes, including environmental, lifecycle, and accelerated aging tests, to assess product performance.

• Examine test results and provide comprehensive reports, highlighting areas for enhancement and potential risks.

• Act as the subject matter expert and technical representative for the reliability engineering function within project teams.

• Suggest design or testing methodologies and statistical process control procedures to achieve the necessary levels of product reliability.

• Lead and manage multiple projects in a dynamic, cross-functional setting.

• Engage in design reviews and collaborate with engineering teams to promote the DFR (Design for Reliability) process.

⛳️ Requirements

• Bachelor’s degree (Advanced degree preferred) in Mechanical /Electrical /Reliability Engineering or a related field.

• Over 10 years of reliability engineering experience in a highly regulated industry, ideally within the medical device sector.

• Prior experience in developing custom verification tests and fixtures.

• Background in planning verification tests (DoE, sample size selection, etc.).

• Proficient in reliability and statistical analysis software such as Reliasoft/PTC Windchill/Minitab.

🏝️ Benefits

• Competitive salary and performance-based bonuses.

• Comprehensive health insurance plans.

• Opportunities for professional development and continuing education.

• Flexible work hours and a supportive work environment.