Sustaining Engineering Associate

FluidAI Medical • Kitchener, ON

2d

About The Position

You'll sit on the R&D team and act as the engineering investigator on non-conformance (NCR) investigations; the cases where something on the production line doesn't behave as designed. The work is detective work: pulling production data, talking to technicians, running bench experiments, and tracing failures back to their root cause in the design, the process, or the materials. From there, you'll work with R&D, manufacturing, and QA to propose fixes that stick. This is an engineering role with a quality-systems backdrop. You'll learn how a real ISO 13485 medical-device QMS operates from the inside and your day-to-day will be investigation, data analysis, and design thinking.

Requirements

• Working towards a technical degree in engineering (mechatronics, biomed, etc.) or similar fields.
• Sharp attention to detail and an instinct for when something looks "off".
• Comfort with root cause analysis methods, or a clear interest in learning them rigorously.
• Strong technical writing: your investigation reports will be read by engineers, regulators, and auditors.
• Comfortable with at least one scripting language (e.g. Python) for data analysis work.
• Solid grounding in descriptive statistics and basic experimental design.
• Comfortable using AI tools (Claude, etc.) to accelerate engineering work with judgment about when not to.

Nice To Haves

• Prior experience with ISO 13485:2016.
• Prior experience in the medical device (or similarly regulated) field.

Responsibilities

• Support NCR investigations end-to-end: scope the issue, design the investigation, run the analysis, document the conclusion.
• Apply structured root cause analysis (5-Whys, fishbone, fault tree, FMEA) to medical device failures.
• Pull and analyze production and test data to identify failure patterns and process drift.
• Design and run bench experiments to reproduce or rule out suspected failure modes.
• Propose design and process improvements; partner with R&D and manufacturing to scope and validate them.
• Support the development of production-line tests that catch issues before they ship.
• Document investigations to a standard that holds up under audit.

Benefits

• Compensation: The pay for this position will be based on average co-op wages as outlined by your academic institution’s co-op program or similar institutions if specific data is unavailable, ensuring fair and competitive compensation aligned with industry and academic standards. The typical range for this role is $22 - $25 per hour for work terms 2-4.
• Grant Eligibility: This position is made possible through wage subsidy grants such as BioTalent SWPP. As such, participants must be a current full-time student registered in a Canadian Post-secondary program. International students are not eligible. Eligible participants must be a Canadian citizen, permanent resident or person who has been granted refugee status in Canada and be legally entitled to work.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree