The Reliability Engineer will work with R&D, quality assurance, and manufacturing teams to develop reliability requirements and implement comprehensive reliability test plans for IVD medical devices. They will also analyze test results, document findings, and recommend improvements to ensure compliance with regulatory standards.

Requirements

Candidates should have a deep understanding of reliability engineering and familiarity with medical device regulations such as ISO 13485 and FDA 21 CFR 820. A bachelor's degree in a relevant field and over 10 years of experience in reliability engineering within a regulated industry are required.

Experience

10+ years

Education

bachelor degree

Working hours

40 hours per week

Job type

Full-time

Work arrangement

On-site

Skills

Reliability Engineering
HALT
HASS
ALT
Statistical Modeling
DFMEA
PFMEA
Fault Tree Analysis
Accelerated Life Testing
DOE
Minitab
JMP
Python
Matlab
Risk Assessment
Design for Reliability

Minimum pay

Maximum pay

100

Pay currency

USD

Pay period

YEAR

Visa sponsorship

Not detected in the job text

Keywords

Reliability Engineering
Medical Device
HALT
HASS
ALT
Statistical Modeling
DFMEA
PFMEA
Fault Tree Analysis
Accelerated Life Testing
DOE
Minitab
JMP
Python
Matlab
ISO 13485
ISO 14971
FDA 21 CFR 820
EU MDR
IEC 60601
IEC 62304
IEC 62366
ISO 10993
ISO 17025
Design for Reliability
Risk Assessment
Verification Tests
Life Data Analysis
Environmental Testing
Lifecycle Testing

Original job description

Title: Reliability Engineer.

Location: Ottawa, Ontario, Canada (Onsite)

Visa: Canadian citizen / PR, Open Work Permit

Exp range: 4+ years in Product/core reliability engineering (Do not need quality / site/asset reliability engineer profiles)

Domain: Medical device/ MedTech domain only.

Requirement

Prioritize candidates with medical device or regulated hardware experience, strong background in reliability engineering, HALT/HASS/ALT, and statistical modeling (Weibull, lognormal).
Technical Evaluation Assess expertise in DFMEA/PFMEA, fault tree analysis, accelerated life testing, DOE, and use of data tools (Minitab/JMP required; Python/Matlab/R preferred).
Regulatory Knowledge Verify familiarity with ISO 13485, ISO 14971, FDA 21 CFR 820, EU MDR/IVDR, IEC 60601, IEC 62304, IEC 62366 1, ISO 10993, and ISO 17025.

Responsibilities

Additional responsibilities for this position are as follows:
Working with R&D, quality assurance and manufacturing teams to develop reliability requirements (including requirements cascade), develop and implement comprehensive reliability test plans for IVD medical devices that align with product development and production processes.
Developing reliability plans and requirements, leading and facilitating Design Failure Mode and Effects Analysis (DFMEA).
Designing and developing test methods and fixtures to assess the performance and durability of IVD devices.
Writing test protocols, training personnel on test procedure, analyzing data and creating final reports.
Conducting reliability tests and documenting results, including environmental, lifecycle, and accelerated aging tests, to evaluate product performance under different conditions and in compliance with relevant regulatory standards and guidelines.
Analyzing test results and providing detailed reports, identifying areas for improvement and potential risks.
Serving as the subject matter expert and technical representative for the reliability engineering function in project teams.
Recommending design or test methods and statistical process control procedures for achieving required levels of product reliability.
Leading and directing multiple projects in a fast-paced, cross-functional environment.
Participating in design reviews and working with engineering to drive DFR (Design for Reliability) process and tools and support in defining and executing reliability plans.
Reviewing device failures, performing root cause investigations, and documenting results in a failure reporting, analysis, and corrective action (FRACAS) system.
Compiling and analyzing performance reports and process control statistics; investigating and analyzing relevant variables potentially affecting product and processes.

Qualifications

You have a deep understanding of design for reliability and reliability engineering.
You have a working knowledge of regulations and best practices for medical device development such as ISO 13485 and 21 CFR 820 as well as IEC 61010, IEC 60601, IEC 62506, IEEE 1413 and IEEE 1332.
You can generate data and perform life data analysis.
You have knowledge of building fixtures and performing Life Data Analysis for in-vitro diagnostics medical products.
You can manage multiple projects and prioritize tasks effectively.
You can communicate effectively with other engineers, managers, and stakeholders.
You have a demonstrated ability to lead, motivate, and collaborate with technical teams and drive results.
You can identify and solve complex problems related to design for reliability.
You can analyze data and identify patterns to develop solutions for potential problems.
You have a strong understanding of engineering principles and are familiar with relevant software and tools.
You can identify and assess risks that can cause delays to project timelines or increase project costs.
You can develop process and methodology to model system and subsystem reliability.
You can work with development teams to drive effective FMEA's and risk reduction.
Required skills to have for the success of this role.
Bachelor s degree (Advanced degree preferred) in Mechanical /Electrical /Reliability Engineering or related discipline.
10+ years reliability engineering experience in highly regulated industry preferably in a medical device industry.
Previous experience creating custom verification tests and fixtures.
Previous experience planning verification tests (DoE, sample size selection, etc.)
Experience in Reliability and statistical analysis software like Reliasoft/PTC Windchill/Minitab

Apply by Nov 23, 2026

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Details last changed Sep 15, 2026. About these details

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