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 understanding of how complex medical products move from an initial idea to a verified, usable, manufacturable, and compliant system.
What We’re Looking For
Foundational Requirements
- 1–3 years of relevant experience in systems engineering, biomedical engineering, product development, medical devices, or a related technical field. We’ll also consider strong new graduates with relevant internship or co-op experience.
- A degree in biomedical, systems, mechanical, electrical, software, or another relevant engineering discipline, supported by a strong technical foundation.
- Experience developing or maintaining product requirements, traceability, interface definitions, or other systems engineering documentation.
- Experience supporting risk management, verification planning, test method development, verification execution, or validation activities.
- Familiarity with medical device design controls, ISO 13485, ISO 14971, IEC 62366-1, regulatory strategy, and the compliance expectations that shape regulated product development.
- The ability to translate user needs, product goals, technical constraints, clinical considerations, and regulatory inputs into clear, testable requirements.
- Strong analytical skills and the ability to break a complex or loosely defined problem into clear, actionable work.
- Technical curiosity. You ask why, challenge assumptions, and investigate issues beyond the first available answer.
- Clear and confident written and verbal communication. You can explain your reasoning, raise concerns when something does not make sense, and contribute constructively when your view differs from others in the room.
- Strong attention to detail, including the ability to identify gaps, conflicting requirements, unclear interfaces, and dependencies that could affect the larger system.
- The ability to contribute effectively to design reviews, technical discussions, and project planning—and to follow through on the resulting decisions and actions.
- A collaborative working style. You can build shared understanding across industrial design, mechanical, electrical, software, quality, regulatory, clinical, manufacturing, and project teams.
- Comfort working at a fast pace. You can make progress with incomplete information, adapt as the product evolves, and maintain technical discipline without waiting for perfect conditions.
- Reliability, initiative, and sound judgment for your level. You know when to investigate independently, when to ask for context, and when to involve someone with deeper expertise.
Preferred Competencies
- Exposure to system architecture, functional decomposition, interface management, or technical tradeoff analysis.
- Experience conducting formative and summative usability studies.
- Experience or academic exposure to Human Factors Engineering/Usability Engineering, or translating user needs into product requirements.
- Familiarity with clinical studies, clinical investigation processes, or investigational medical devices.
- Experience developing or supporting software as a medical device, including products that combine software, hardware, user interaction, and clinical workflows.
- Experience supporting medical devices from early definition through verification, validation, regulatory submission, manufacturing transfer, or production.
- Experience working in a start-up, scale-up, consultancy, or another environment where priorities move quickly and individuals take broad ownership.
- Experience working in both small and large organizations, with an understanding of how to adapt your communication, process, and decision-making to different operating environments.
- Familiarity with requirements management, risk analysis, system modelling, test management, usability, or technical documentation tools.
- Internship, co-op, academic, or professional experience in medtech, healthcare, life sciences, or another regulated industry.
How We Work
The best technical answer starts with understanding the people who will use the product, the clients bringing it to market, and the teams responsible for building it. We expect you to consider that context as part of the engineering work.
Our projects rarely begin with a perfectly defined problem. You’ll need to make progress with incomplete information, ask why, challenge assumptions, and help the team identify which questions matter most.
We move quickly, but we do not use speed as an excuse for weak thinking. You should be able to make practical decisions, document your reasoning, and adjust when new evidence changes the path forward.
Complex products take testing, rework, and persistence. We expect you to learn from what does not work, improve the next version, and avoid repeating the same mistake.
You’ll work across several disciplines, so you need to share context, listen carefully, and communicate decisions clearly. Strong collaboration here does not mean avoiding disagreement. It means having the confidence to raise a concern, explain why it matters, and help the team reach a better answer.
We also expect initiative. When you notice a gap or see a better approach, raise it, propose a path forward, and help carry the solution through.
Show Us What You’ve Done
Show us work that demonstrates how you think, what you owned, and how you contributed.
That could include professional work, internships, co-ops, research, capstone projects, start-up work, or other hands-on technical experience. We’re especially interested in examples where you:
- Turned a loosely defined need into clear technical requirements.
- Helped manage risk, verification, usability, or regulatory constraints.
- Supported the development of an investigational or clinically evaluated device.
- Identified a technical or process issue and raised it before it became a larger problem.
- Worked across disciplines to move a complex product forward.
- Adapted to a fast-changing environment without losing control of the details.
Be specific about your role. Tell us what you owned, what constraints you faced, what questions you asked, what decisions you influenced, and what changed because of your contribution.
Think You're a Fit?
This role will suit someone who wants to build strong systems engineering foundations while working on real products with experienced, multidisciplinary teams.
You do not need to have seen every part of the development process before. You do need to bring technical curiosity, confidence, sound judgment, and the willingness to speak up when the work needs a sharper question or a better answer.
If you want broad exposure, meaningful responsibility, and the chance to help shape technically demanding medical products, we’d like to hear from you.
Pay: $75,000.00-$90,000.00 per year
Benefits:
- Casual dress
- Company events
- Dental care
- Extended health care
- Flexible schedule
- Profit sharing
- Vision care
Ability to commute/relocate:
- Toronto, ON M5V 2G5: reliably commute or plan to relocate before starting work (required)
Education:
- Bachelor's Degree (required)
Work Location: Hybrid remote in Toronto, ON M5V 2G5
