Job Summary:
You’ll be directly responsible for keeping Stream Platform’s production running well and improving it over time. When something on the line doesn’t behave as designed, you’ll be the technical resource who helps find out why: pulling production data, talking to technicians, running bench experiments, and tracing failures back to the design, the process, or the materials. You’ll work with team members on technical investigations, flag recurring issues, and work with R&D, Manufacturing, and Quality to put fixes in place that stick.
Beyond NCRs, you’ll run product testing (verification, validation, and qualification builds), support ECOs from proposal through release, and move improvements into manufacturing through updated work instructions, SOPs, test methods, and training. You’ll also de-risk the supply chain by testing alternative materials and suppliers, keeping backups on the BOM, and finding ways to reduce COGS.
This is an engineering role at the meeting point of Manufacturing, R&D, and Quality. You’ll connect production, design, and the quality system, so a problem found on the line turns into a fix that works in all three. You’ll work inside a real ISO 13485 medical-device QMS, and your day-to-day will be investigation, testing, data analysis, and hands-on problem-solving, with ownership of long-term sustaining projects.
Note: This is an office-first role working out of our Kitchener HQ in the Medical Innovation Xchange
Job Responsibilities:
- Manage and run product testing (verification, validation, and qualification builds). Run preliminary testing on proposed ECOs to prototype design changes before committing.
- Propose and improve test protocols within the QMS.
- Find and test alternative suppliers, manage backup suppliers on the BOM, and reduce COGS.
- Monitor metrics and trends from Quality, Engineering, and Manufacturing to inform solutions and proposals to improve Stream Platform
- Support ECOs from proposal through verification and release, with Quality support.
- Manage inventory & materials on hand for formal testing and R&D work, and support or lead R&D activities as needed.
- Own long term sustaining projects such as component changes, supplier issues, and sensor or calibration performance.
Qualifications:
These are some of the skills we are looking for in an ideal candidate. If you check some but not all of these boxes, please apply anyway!
- 1-3 years of engineering experience in manufacturing, sustaining, quality, R&D, or product development (internships and co-op terms count), ideally in medical devices or another regulated industry
- Degree in engineering (biomedical, mechanical, electrical, chemical, or similar)
- Basic understanding of manufacturing processes and quality systems
- Clear technical writing and problem-solving skills
- Comfortable on the production floor and working with data
- Self driven - comfortable driving decisions
- Excellent written and verbal technical communication skills as demonstrated in regular reporting (e.g. weekly)
- Ability to work in a high-pressure environment and constantly changing conditions
Bonus Qualifications:
- Exposure to ISO 13485 or another regulated environment
- Experience with sensors, calibration, or analytical instruments
- Experience with NCR/CAPA or change control
- Root cause methods (5 Whys, fishbone, 8D)
- Basic data analysis (Excel, Python, or similar)
- Familiarity with design controls and risk management (ISO 14971)
- Prior experience in the medical device (or similarly regulated) field is an asset
Transparency & Hiring Practices:
- Compensation: The salary range for this position is $65,000 - $80,000 CAD annually.
- Application Screening: All applications are screened manually. We do not use AI or AI-Augmented Applicant Tracking Systems (ATS) to screen, assess, reject, or select candidates.
- Position Status: This job posting is for an active vacancy within our organization.
