Job Description

The Human Factors Engineer supports the development and commercialization of innovative

Job Title: Human Factors Engineer

Job Description

The Human Factors Engineer supports the development and commercialization of innovative medical devices and healthcare technologies. This role integrates usability engineering and user‑centred design principles throughout the product‑development lifecycle to ensure products are safe, intuitive, and effective for healthcare professionals and other end users.

You will collaborate closely with systems, software, mechanical, electrical, clinical, quality, regulatory, and product teams to translate user needs into robust product requirements. The position contributes to new‑product development, product enhancements, and sustaining initiatives from early‑stage user research through usability validation and regulatory submission.

Responsibilities

- Develop and execute human factors and usability engineering plans for medical‑device development programs.
- Identify intended users, use environments, clinical workflows, critical tasks, and foreseeable use‑related risks.
- Translate user needs and clinical workflows into clear, testable product and user‑interface requirements.
- Plan, conduct, and document user interviews, workflow observations, contextual research, and usability studies.
- Design and execute formative usability evaluations using prototypes, simulated‑use environments, and production‑equivalent devices.
- Plan and support summative usability validation studies for regulatory purposes, including study protocols, moderator guides, participant profiles, data‑collection tools, and final reports.




- Analyze qualitative and quantitative usability data and communicate findings and recommendations to engineering and program stakeholders.
- Facilitate use‑related risk analyses and support the identification and prioritization of critical tasks.
- Ensure usability risks are appropriately linked to product risk‑management documentation and design controls.
- Collaborate with designers and engineers to improve physical interfaces, graphical user interfaces, instructions for use, packaging, labelling, and training materials.
- Evaluate design changes for their impact on usability, clinical workflow, and use‑related risk.
- Maintain usability engineering files and ensure documentation is complete, traceable, compliant, and audit‑ready.
- Partner with Quality and Regulatory teams to support submissions, design reviews, audits, and responses to human factors‑related regulatory questions.
- Coordinate with external research facilities, healthcare professionals, recruiting partners, and usability‑testing vendors when required.
- Advocate for the needs and perspectives of healthcare professionals and other end users throughout the product lifecycle.

Must Haves

- Bachelors degree in Human Factors Engineering, Ergonomics, Biomedical Engineering, Systems Engineering,



Psychology, Cognitive Science, Industrial Design, or a related discipline.
- 3+ years of human factors or usability engineering experience within medical devices, healthcare technology, or another highly regulated product setting.
- Experience applying human factors activities throughout the product‑development lifecycle.
- Demonstrated experience planning, moderating, and documenting formative usability studies.
- Experience supporting or executing summative usability validation studies.
- Working knowledge of IEC 62366‑1 or equivalent usability‑engineering practices.
- Understanding of regulatory expectations surrounding human factors and usability for medical devices.
- Experience with use‑related risk analysis, critical‑task identification, and evaluation of risk controls.
- Familiarity with design controls, product requirements, traceability, verification, and validation.
- Ability to translate user research and usability findings into actionable engineering requirements and design recommendations.
- Experience developing usability protocols, participant‑screening criteria, moderator guides, and study reports.
- Solid written communication and technical‑documentation skills.
- Ability to collaborate effectively across engineering, clinical, regulatory, quality, and product teams.
- Ability to work onsite in the Lower Mainland, BC for product evaluations, collaboration, and usability‑testing activities.

Nice to Haves

- Masters degree in Human Factors, Ergonomics, Biomedical Engineering, Cognitive Psychology, or a related fie

📌 Human Factors Engineer (Vancouver)
🏢 Actalent
📍 Vancouver