System Designer

Our client, a Medical Devices / Healthcare company, is looking for a System Designer for their Montreal, QC location.
 
Responsibilities:

• This role is part of a cross-functional design and service transfer project focused on improving the serviceability and reliability of robotic-assisted surgical systems. The project involves updating Design History File (DHF) documentation, defining servicing design inputs, creating job cards and spare part technical specifications, and supporting servicing verification and validation activities. The candidate will work closely with R&D, Service Engineering, Quality, Operations, and Field Service teams to ensure that design outputs are properly translated into production and servicing specifications in compliance with applicable regulatory frameworks.
• The work is delivered in an agile environment with iterative planning cycles, backlog grooming, and regular cross-functional alignment. The successful candidate will be comfortable operating within a fast-paced, collaborative team structure where priorities may evolve and adaptability is essential.

• The ideal candidate will have a solid background in system design and product development, with direct experience in regulatory compliance and documentation. You'll play a key role in refining existing product documentation and ensuring continued regulatory alignment as part of an accelerated product remediation and continuous improvement initiative.
• Candidates must have experience with software as a medical device (SaMD) concepts and familiarity with robotic or electromechanical medical device platforms.
• 5+ years of experience in system design and/or product development within the medical device industry.
• Strong experience in system design in a multi-disciplinary organization, preferably involving robotic or electromechanical medical devices.
• Experience drafting and maintaining DHF (Design History File) content, including user needs, system requirements, design inputs, traceability matrices, and risk documentation.
• Demonstrated ability to define servicing design inputs and translate them into actionable design outputs such as job cards (spare part replacement, planned maintenance, troubleshooting, and installation instructions) and spare part technical specifications.
• Experience with design transfer and/or service transfer processes — translating device design into production and servicing specifications, including preventive maintenance plans and servicing manuals/work instructions.
• 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 (including servicing verification and validation), and ensure traceability in collaboration with the Product
• Development and Service Engineering teams.
• Experience with or understanding of component reliability analysis, including mean time to failure (MTTF) data, impact analysis for serviceable components, and worst-case servicing condition validation.
• Knowledge of applicable regulatory frameworks including 21 CFR 820 (Quality System Regulation), ISO 13485, EU MDR, and FDA guidance on remanufacturing/refurbishment of medical devices.
• Strong interpersonal and collaboration skills; proven ability to work effectively within cross-functional teams spanning R&D, QA, Service Engineering, Operations, Supply Chain, and regulatory functions.
• Ability to build consensus, navigate differing perspectives, and foster constructive working relationships across disciplines and organizational levels.
• Able to clearly translate technical information for diverse stakeholders, adapting communication style to both technical and non-technical audiences.
• Demonstrated ability to proactively identify and resolve cross-team dependencies, escalate blockers constructively, and maintain alignment across workstreams.
• Hands-on experience executing projects in an Agile or hybrid Agile environment, including
• participation in sprint planning, backlog grooming, daily stand-ups, and retrospectives.
• Comfortable working with iterative delivery cycles, managing shifting priorities, and contributing to continuous improvement of team processes.
• Experience with Codebeamer and/or JIRA, or similar requirements management, traceability, and Agile project tracking tools.
• Must have experience in a regulatory environment with strict compliance, including CAPA-driven improvement projects.
• Strong analytical skills and accurate judgment-making skills.
• Ability to deal effectively with internal and external collaborators in a cross-functional, multi-site environment.
• Excellent communication skills; written and verbal.
• Experience with SSRS (System Service Specification Requirements) creation and verification.
• Familiarity with lifecycle testing methodologies for serviceable components and systems.
• Experience supporting spare part forecasting, demand planning, or BOM management in a servicing context.
• Understanding of field change order (FCO) processes and deployment to fielded units.
• Experience with ServiceMax or similar field service management platforms.
• Prior involvement in refurbishment or redeployment programs for capital medical equipment.
• Certified Scrum Master (CSM), SAFe Agilist, or equivalent Agile certification.
• Experience facilitating cross-functional workshops, design reviews, or sprint demos in a regulated environment.
• Bachelor's degree in engineering or science related field; biomedical, mechanical, or systems engineering preferred.

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities