Biomedical Engineer | Systems Engineer The Opportunity

Located in Toronto’s design district near King & Spadina, Cortex Design is a full-service product development firm specializing in the design and engineering of technically complex medtech products.

We’re hiring a Biomedical Engineer to join our Systems Engineering team. You’ll help turn user needs, product requirements, technical constraints, and regulatory considerations into a clear development path that multidisciplinary teams can design, build, and test against.

We’re looking for someone with a strong technical foundation, baseline knowledge of medical device regulatory strategy and compliance, and the confidence to raise concerns when something does not add up. You should be curious enough to ask why, practical enough to keep moving when every answer is not yet available, and disciplined enough to maintain technical rigour in a fast-moving environment.

This is an early-career role with meaningful exposure to the full product development process. You’ll contribute to requirements, system architecture, risk management, verification, usability, clinical considerations, and cross-functional technical decisions. You may support products ranging from early concepts to investigational devices used in clinical studies.

We’re targeting candidates with 1–3 years of relevant experience, but we’ll also consider strong new graduates with relevant internship or co-op experience. Experience in a start-up, consultancy, scale-up, or another environment where people move quickly and take broad ownership will be especially valuable.

This is a hybrid role based in downtown Toronto, with approximately 70% in-office and 30% remote work. Compensation for this role is $75,000–$90,000 CAD, commensurate with experience. Health benefits and profit sharing are provided.

What are WE Like?

We’re not your average medtech consultancy.

Cortex is an ISO 13485-certified, design-led firm that lives at the intersection of human-centred design and engineering excellence. We exist to create beautiful, life-changing experiences that substantially improve human quality of life.

We’ve helped clients develop award-winning, emotionally resonant products that span healthcare and consumer markets—and we’re just getting started. Our team is multidisciplinary, collaborative, fast-moving, and deeply invested in client success.

We’re also the only Canadian team ever to win an XPRIZE, and we take pride in blending artistry with technical rigour.

Clients come to us because they want products that are intuitive, beautiful, and engineered with discipline. Our downtown studio houses everything from early research and prototyping to precision assembly, giving us the ability to move fast and deliver with confidence.

If you want an inside look at how we think and work, check out our website, follow us on LinkedIn, or explore our blog.

What You’ll Do

• Translate user needs, product goals, technical constraints, clinical considerations, and regulatory inputs into clear, testable system requirements.
• Generate, compile, and maintain robust Medical Device File documentation and Usability Engineering File inputs to support successful regulatory submissions (e.g., FDA 510(k), Health Canada) and that keeps development aligned.
• Contribute to system architecture by breaking complex problems into manageable parts, identifying dependencies, and helping the team work through technical tradeoffs.
• Support risk management activities, including hazard identification, risk analysis, risk controls, and generating the evidence needed to show that those controls work.
• Help plan and execute verification and validation activities, including test method development, protocol preparation, testing, results analysis, and reporting.
• Support formative and summative usability evaluations, utilizing user research to design comprehensive study protocols and leveraging the findings to refine product requirements and validate risk controls.
• Contribute to the development of products intended for clinical studies, including investigational devices that require careful coordination across engineering, quality, regulatory, and clinical teams.
• Work closely with industrial design, mechanical, electrical, software, quality, regulatory, clinical, manufacturing, and project teams throughout development.
• Spot gaps, conflicting requirements, unclear interfaces, and technical dependencies early, then work with the right people to resolve them.
• Come prepared to design reviews and technical discussions, voice concerns clearly, and follow through on the decisions and actions that come out of them.
• Help teams move quickly without losing control of requirements, risks, evidence, or documentation.
• Build a practical