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, robust 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.

📌 System Designer (Montreal)
🏢 Mantu
📍 Montreal