System Designer

Title: System Designer

Duration: 12 Months

Location: Montreal, H3C 2N6

Work Model: (Hybrid) Monday to Friday, 3 days onsite, 2 days WFH

Role Overview:

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.

Key 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.

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

Applicant Notices & Disclaimers

• For information on benefits, equal opportunity employment, and location-specific applicant notices, click here

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.The pay rate for this position is C$50.00/hr.