Reliability Engineer

About This Opportunity

We are representing a confidential medical device organization seeking an experienced Reliability Engineer to join their product development team in Canada. Our client specializes in in-vitro diagnostic devices and operates in a highly regulated environment requiring deep expertise in reliability methodologies and regulatory compliance.

Responsibilities

In this role, you will:

• Collaborate with R&D, quality assurance, and manufacturing teams to develop reliability requirements and implement comprehensive reliability test plans for diagnostic medical devices
• Develop reliability plans and lead Design Failure Mode and Effects Analysis (DFMEA) sessions
• Design and develop test methods and fixtures to assess performance and durability of devices, including writing protocols, training personnel, analyzing data, and creating reports
• Conduct reliability tests including environmental, lifecycle, and accelerated aging tests to evaluate product performance under various conditions in compliance with regulatory standards
• Analyze test results and provide detailed reports identifying areas for improvement and potential risks
• Serve as the subject matter expert and technical representative for reliability engineering within project teams
• Recommend design or test methods and statistical process control procedures to achieve required reliability levels
• Lead and direct multiple projects in a fast-paced, cross-functional environment
• Participate in design reviews and drive Design for Reliability (DFR) processes and tools
• 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, investigating variables affecting products and processes

What We're Looking For

Required qualifications:

• Bachelor's degree in Mechanical, Electrical, Reliability Engineering or related discipline (advanced degree preferred)
• 10+ years of reliability engineering experience in a highly regulated industry, preferably medical devices
• Deep understanding of design for reliability and reliability engineering principles
• Working knowledge of medical device regulations and standards including ISO 13485, 21 CFR 820, IEC 61010, IEC 60601, IEC 62506, IEEE 1413, and IEEE 1332
• Experience creating custom verification tests and fixtures
• Experience planning verification tests including Design of Experiments (DoE) and sample size selection
• Proficiency with reliability and statistical analysis software such as Reliasoft, PTC Windchill, or Minitab
• Ability to generate data and perform life data analysis
• Experience building fixtures and performing Life Data Analysis for in-vitro diagnostics medical products

Highly valued expertise:

• Strong background in HALT/HASS/ALT (Highly Accelerated Life Testing, Highly Accelerated Stress Screening, Accelerated Life Testing)
• Statistical modeling experience with Weibull, lognormal distributions
• Expertise in DFMEA/PFMEA, fault tree analysis, accelerated life testing, and DOE
• Proficiency with data analysis tools (Minitab/JMP required; Python/Matlab/R preferred)
• Familiarity with ISO 14971, FDA 21 CFR 820, EU MDR/IVDR, IEC 62304, IEC 62366-1, ISO 10993, and ISO 17025
• Demonstrated ability to lead, motivate, and collaborate with technical teams
• Strong problem-solving skills for complex reliability challenges
• Excellent communication skills with engineers, managers, and stakeholders
• Ability to manage multiple projects and prioritize effectively

How We Work With You

Candidates apply directly through Get A Job.ai. Our talent team will conduct an initial screening to assess your qualifications and fit for this role. Qualified candidates will then be submitted to our client for their consideration. Please do not attempt to contact the client directly, as all communications should flow through our recruitment process to ensure proper representation.

Pay

Compensation details will be discussed during the screening process based on experience and qualifications.

Equal Employment Opportunity: Get A Job.ai is committed to inclusive hiring practices and equal opportunity employment. We welcome applications from all qualified candidates regardless of race, color, religion, sex, national origin, age, disability, or any other protected characteristic.