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About the job
System Engineer / System Designer | Medical Devices | Robotic Surgery | Montreal
Mission Description
We are seeking an experienced System Engineer / System Designer to support the improvement, regulatory remediation, and service transfer of robotic-assisted surgical systems. The role focuses on updating Design History File (DHF) documentation, defining servicing requirements, developing technical service documentation, and supporting verification and validation activities.
The successful candidate will work closely with R&D, Service Engineering, Quality, Operations, and Field Service teams to improve system reliability and serviceability while ensuring compliance with applicable medical device regulations. The role operates in an Agile environment, requiring adaptability, strong collaboration, and the ability to manage evolving priorities.
Key Responsibilities
- Develop, maintain, and remediate DHF documentation, including user needs, system requirements, design inputs/outputs, traceability matrices, and risk documentation.
- Define servicing design inputs and translate them into technical outputs such as job cards, spare-part specifications, troubleshooting instructions, installation procedures, and preventive maintenance documentation.
- Support design and service transfer activities, ensuring product design information is accurately translated into production and servicing specifications.
- Support risk management and V&V activities, including uFMEA, ISO 14971 risk analysis, testable requirements, V&V protocols, and servicing verification/validation.
- Analyze component and system reliability, including MTTF data, serviceable component impact, worst-case servicing conditions, and opportunities to improve system reliability.
- Collaborate with R&D, Quality, Service Engineering, Operations, Supply Chain, and Field Service teams in an Agile environment to resolve dependencies, manage requirements and traceability, and ensure regulatory compliance.
Qualifications
- Bachelor’s degree in Engineering or Science, preferably Biomedical, Mechanical, or Systems Engineering, with 5+ years of medical device system design/product development experience.
- Strong experience with systems engineering and multidisciplinary product development, ideally involving robotic, electromechanical, or surgical medical devices.
- Hands-on experience with DHF documentation, requirements management, design inputs/outputs, traceability, design/service transfer, and technical documentation.
- Strong knowledge of medical device risk management and regulatory requirements, including ISO 14971, ISO 13485, FDA 21 CFR 820, EU MDR, and CAPA-driven improvement initiatives.
- Experience supporting verification & validation, requirements testing, uFMEA/FMEA, and usability/risk mitigation, with familiarity with IEC 62366 and SaMD concepts preferred.
- Strong cross-functional communication and collaboration skills, with experience working in Agile/hybrid Agile environments and using tools such as Codebeamer, JIRA, or similar requirements/project tracking platforms.
Preferred Experience
- SSRS / System Service Specification Requirements
- Reliability analysis and MTTF
- BOM management and service parts
- Field Change Orders (FCO)
- ServiceMax or similar field-service platforms
- Refurbishment/redeployment of capital medical equipment
- Scrum Master, SAFe, or equivalent Agile certification
- Surgical robotics experience
Position Details
- Industry: Medical Devices / Robotic Surgery
- Location: Montreal, Canada
- Employment Type: Permanent
- Environment: Agile / Cross-functional
- Ideal Background: Medical device systems/product development experience.
