System Designer

ICONMA, LLC

9 hours ago

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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?

System Designer · ICONMA, LLC