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 workplace 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.

📌 Concepteur Bureau d' F/H (Montreal)
🏢 Amaris Consulting
📍 Montreal