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Amaris Consulting | Part of Mantu

System Designer

Montreal, QC, Canada

Full-time

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Job details

Job type: Full-time
Apply by: Dec 6, 2026
Experience: 5+ years of experience in system design within a multidisciplinary organization
Posting language: English
Posted: Nov 6, 2026

Original job description

We are seeking a System Designer to lead assigned system design activities within New Product Introduction (NPI) projects for computer-assisted surgical and robotic systems. In this role, you will own technical deliverables across system requirements, design inputs, architecture support, risk management, verification and validation, usability engineering, design changes, and Design History File (DHF) documentation.

You will work independently to drive product features, subsystems, or projects forward, while taking part in hands-on robotic testing and integration activities and collaborating closely with multidisciplinary project teams.

Location: Montreal, Quebec

Work Mode: Hybrid (minimum three days per week in office)

Travel: Up to 25% is required

Key Responsibilities

Lead assigned system design activities within NPI projects for computer-assisted surgical and robotic systems
Define and maintain system requirements and design inputs, ensuring they are clear, testable, and traceable
Support system architecture development and decisions
Draft and maintain DHF content, including user needs, system requirements, design inputs, traceability matrices, and risk documentation
Support risk management activities, including risk analysis (e.g., uFMEA), and contribute to design mitigations
Contribute to usability planning and usability engineering activities
Support the development of verification and validation (V&V) protocols in collaboration with the Product Development team
Manage and document design changes in accordance with applicable procedures
Participate in hands-on robotic testing and integration activities
Independently drive technical deliverables for assigned product features, subsystems, or projects
Collaborate with R&D, QA, clinical, and regulatory teams, translating technical information clearly for diverse stakeholders
Engage effectively with both internal and external collaborators

Qualifications

Bachelor’s degree in engineering, science, or a related technical field (e.g., biomedical, computer, mechanical, or electrical engineering)
A degree in biomedical engineering is an asset
5+ years of experience in system design within a multidisciplinary organization
Experience working in a regulatory environment with strict compliance requirements
Experience drafting and maintaining DHF content, including user needs, system requirements, design inputs, traceability matrices, and risk documentation
Experience with Codebeamer, Windchill, and/or JIRA, or similar tools
English required

Knowledge and Skills

Familiarity with ISO 14971 (required)
Familiarity with IEC 62366 (preferred)
Ability to support risk analysis (e.g., uFMEA) and contribute to usability planning and design mitigations
Ability to define testable requirements, support V&V protocol development, and ensure traceability
Strong analytical skills and sound judgment
Excellent written and verbal communication skills
Strong collaboration skills across R&D, QA, clinical, and regulatory functions
Ability to deal effectively with internal and external collaborators

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.

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More about this job

Responsibilities

Lead system design activities for new product introduction projects involving computer-assisted surgical and robotic systems, owning requirements, design inputs, architecture support, risk management, usability, verification and validation, and design documentation. Drive technical deliverables for assigned features, subsystems, or projects, participate in robotic testing and integration, and collaborate with multidisciplinary teams.

Requirements

Requires a bachelor's degree in engineering, science, or a related technical field and at least five years of system design experience in a multidisciplinary organization. Candidates should have regulatory-environment experience, familiarity with ISO 14971, experience maintaining Design History File documentation, and the ability to define testable requirements and support risk, usability, and verification activities.

Skills

System Design
System Requirements
Design Inputs
System Architecture
Risk Management
uFMEA
Usability Engineering
Verification And Validation
Requirements Traceability
Robotic Testing And Integration
Design Change Management
Regulatory Compliance
ISO 14971
IEC 62366
Cross-Functional Collaboration

Benefits

Training And Development
Internal Academy
Team-Building Events

Visa sponsorship

Not detected in the job text

Keywords

New Product Introduction
Computer-Assisted Surgery
Robotic Systems
System Design
System Requirements
Design Inputs
System Architecture
Design History File
Traceability Matrices
Risk Management
uFMEA
ISO 14971
IEC 62366
Usability Engineering
Verification And Validation
V&V Protocols
Robotic Testing
System Integration
Regulatory Compliance
Design Change Management
Codebeamer
Windchill
JIRA
Multidisciplinary Teams
Biomedical Engineering
Mechanical Engineering
Electrical Engineering
Computer Engineering

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