System Designer

We are seeking a System Designer to lead assigned system design activities within New Product Introduction (NPI) projects for computer-assisted surgical and robotic systems. In this role, you will own technical deliverables across system requirements, design inputs, architecture support, risk management, verification and validation, usability engineering, design changes, and Design History File (DHF) documentation.

You will work independently to drive product features, subsystems, or projects forward, while taking part in hands-on robotic testing and integration activities and collaborating closely with multidisciplinary project teams.

Location: Montreal, Quebec

Work Mode: Hybrid (minimum three days per week in office)

Travel: Up to 25% is required

Key Responsibilities

• Lead assigned system design activities within NPI projects for computer-assisted surgical and robotic systems
• Define and maintain system requirements and design inputs, ensuring they are clear, testable, and traceable
• Support system architecture development and decisions
• Draft and maintain DHF content, including user needs, system requirements, design inputs, traceability matrices, and risk documentation
• Support risk management activities, including risk analysis (e.g., uFMEA), and contribute to design mitigations
• Contribute to usability planning and usability engineering activities
• Support the development of verification and validation (V&V) protocols in collaboration with the Product Development team
• Manage and document design changes in accordance with applicable procedures
• Participate in hands-on robotic testing and integration activities
• Independently drive technical deliverables for assigned product features, subsystems, or projects
• Collaborate with R&D, QA, clinical, and regulatory teams, translating technical information clearly for diverse stakeholders
• Engage effectively with both internal and external collaborators

Qualifications

• Bachelor’s degree in engineering, science, or a related technical field (e.g., biomedical, computer, mechanical, or electrical engineering)
• A degree in biomedical engineering is an asset
• 5+ years of experience in system design within a multidisciplinary organization
• Experience working in a regulatory environment with strict compliance requirements
• Experience drafting and maintaining DHF content, including user needs, system requirements, design inputs, traceability matrices, and risk documentation
• Experience with Codebeamer, Windchill, and/or JIRA, or similar tools
• English required

Knowledge and Skills

• Familiarity with ISO 14971 (required)
• Familiarity with IEC 62366 (preferred)
• Ability to support risk analysis (e.g., uFMEA) and contribute to usability planning and design mitigations
• Ability to define testable requirements, support V&V protocol development, and ensure traceability
• Strong analytical skills and sound judgment
• Excellent written and verbal communication skills
• Strong collaboration skills across R&D, QA, clinical, and regulatory functions
• Ability to deal effectively with internal and external collaborators

Why choose us

• An international community bringing together more than 110 different nationalities
• An environment where trust is central: 70% of our leaders started their careers at the entry level
• A strong training system with our internal Academy and more than 250 modules available
• A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.)

Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.