Our Client, a Medical Devices / Healthcare company, is looking for a System Designer for their Montreal, QC/Hybrid location.

Responsibilities:

- Responsible for leading assigned system design activities within New Product Introduction (NPI) projects for computer-assisted surgical and robotic systems, including system requirements, design inputs, system architecture support, risk management, verification and validation, usability engineering, Design Changes, and Design History File (DHF) documentation.

- This role independently drives technical deliverables for assigned product features, subsystems, or projects, participates in hands-on robotic testing and integration activities, and collaborates across multidisciplinary project teams.

Requirements:

- 5+ years of experience

- Strong experience in system design in a multi-disciplinary organization.

- Experience drafting and maintaining DHF (design history file) content, including user needs, system requirements, design inputs, traceability matrices, and risk documentation.

- Able to support risk analysis (e.g uFMEA etc) and contribute to usability planning and design mitigations.





- Familiarity with ISO 14971 is required, and IEC 62366 preferred.

- Ability to define testable requirements, support V&V; protocol development, and ensure traceability in collaboration with the Product Development team.

- Strong collaboration skills across R&D;, QA, clinical, and regulatory functions; able to clearly translate technical information across stakeholders.

- Must have experience in a regulatory environment with strict compliance.

- Strong analytical skills and accurate judgment making skills.

- Ability to deal effectively with internal and external collaborators.

- Excellent communications skills; written and verbal.

- Experience with Codebeamer, windchill, and/or JIRA, or similar.

- Bachelor's degree in engineering, science, biomedical engineering, computer engineering, mechanical engineering, electrical engineering, or a related technical field. Biomedical engineering is an asset.

Why Should You Apply?

- Health Advantages

- Referral Program

- Excellent growth and advancement opportunities

📌 System Designer (Montreal)
🏢 Iconma Portal
📍 Montreal