System Designer

We are seeking an experienced System Designer to support the design improvement and regulatory remediation of robotic-assisted surgical and electromechanical medical device systems. This role sits within a cross-functional design and service transfer initiative focused on improving the serviceability and reliability of complex medical device platforms. You will work at the intersection of R&D, Service Engineering, Quality, Operations, and Field Service to ensure that design outputs are properly translated into production and servicing specifications, in full compliance with applicable regulatory frameworks. This is a fast-paced, agile environment with iterative planning cycles, backlog grooming, and regular cross-functional alignment — ideal for someone who thrives on adaptability and continuous improvement. Candidate should bring experience with software as a medical device (SaMD) concepts and familiarity with robotic or electromechanical medical device platforms. Location: Montreal Work mode: candidate must be available to work hybrid and on-site Key Responsibilities Support design improvement and regulatory remediation of robotic-assisted surgical and electromechanical medical device systems Maintain and update Design History File (DHF) documentation in accordance with applicable medical device regulations and quality procedures Define and document system requirements, design inputs/outputs, servicing requirements, and technical specifications Develop and maintain traceability matrices linking requirements, risks, design outputs, and verification activities Create and update technical service documentation, including service procedures, maintenance requirements, troubleshooting guides, and service specifications Support Design Transfer and Service Transfer activities to ensure effective handoff to manufacturing and field service teams Participate in Verification & Validation (V&V) activities, including test planning, execution, documentation, and issue resolution Support risk management activities, including uFMEA/FMEA, risk assessments, and implementation of risk controls per ISO 14971 Support CAPA, reliability, and regulatory remediation initiatives to improve system reliability, serviceability, and compliance Collaborate with R&D, Service Engineering, Quality, Operations, and Field Service teams to identify and implement system improvements Ensure system design and technical documentation comply with applicable FDA, 21 CFR 820, ISO 13485, and EU MDR requirements Manage requirements, technical documentation, and engineering activities using tools such as JIRA and Codebeamer within an Agile/Scrum environment Support BOM management, preventive maintenance, Field Change Orders (FCOs), and refurbishment programs as required Contribute to reliability analysis, including MTTF assessments and identification of opportunities to improve system performance and serviceability Participate in cross-functional Agile/Scrum or SAFe teams to deliver system improvements and regulatory remediation activities Requirements Bachelor's degree in engineering or a related science field required; biomedical, mechanical, or systems engineering preferred 5+ years of experience in system design and/or product development within the medical device industry Strong experience in system design within a multi-disciplinary organization, preferably involving robotic or electromechanical medical devices Experience drafting and maintaining DHF 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 Ability to support risk analysis (e.g., uFMEA) and contribute to usability planning and design mitigations Familiarity with ISO 14971 required; IEC 62366 preferred Ability to define testable requirements, support V&V protocol development (including servicing verification and validation), and ensure traceability in collaboration with Product Development and Service Engineering teams Experience with or understanding of component reliability analysis, including MTTF data, impact analysis for serviceable components, and worst-case servicing condition validation Knowledge of applicable regulatory frameworks, including 21 CFR 820, ISO 13485, EU MDR, and FDA guidance on remanufacturing/refurbishment of medical devices Strong interpersonal and collaboration skills, with proven ability to work effectively across 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 Ability to clearly translate technical information for diverse stakeholders, adapting communication style to 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 sprint planning, backlog grooming, daily stand-ups, and retrospectives Comfortable working with iterative delivery cycles, managing shifting priorities, and contributing to continuous process improvement Experience with Codebeamer and/or JIRA, or similar requirements management, traceability, and Agile project tracking tools Experience in a regulatory environment with strict compliance requirements, including CAPA-driven improvement projects Strong analytical skills and sound judgment Ability to work effectively with internal and external collaborators in a cross-functional, multi-site environment Excellent written and verbal communication skills Fluent English required Preferred Qualifications 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 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.

Support the design improvement and regulatory remediation of robotic-assisted surgical and electromechanical medical device systems. Ensure design outputs are translated into production and servicing specifications while maintaining compliance with FDA and ISO standards.

Requires a Bachelor's degree in engineering and 5+ years of experience in medical device system design. Must be proficient in DHF documentation, risk analysis, and working within an Agile environment.

• Internal Academy with over 250 modules • Inclusive work environment • Internal events and team buildings

• JiraSouhaitée

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• System Design
• Medical Device Regulations
• Design History File (DHF)
• Risk Management
• Verification & Validation
• Design Transfer
• Agile/Scrum
• ISO 14971
• ISO 13485
• 21 CFR 820
• EU MDR
• JIRA
• Codebeamer
• FMEA
• Software as a Medical Device (SaMD)
• Reliability Analysis

• Engineering
• Healthcare
• Consulting
• Manufacturing
• Technology

Formation minimale

Baccalauréat

Expérience minimale

5+ ans

Postuler avant le

25 sept. 2026

Langue de l’offre

anglais

Heures de travail

40 heures par semaine

Niveau d’expérience

Mid-Senior level

Mode de candidature

La candidature directe est offerte