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Amaris Consulting | Part of Mantu

Concepteur de Systèmes

Montreal, QC, Canada

Full-time

Apply About employer

Applications open in a new tab.

Job details

Job type: Full-time
Apply by: Dec 2, 2026
Experience: 5+ years of experience in system design within a multidisciplinary organization
Posting language: English · French
Posted: Nov 2, 2026

Original job description

English section of this bilingual listing.

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.

Read the full bilingual original

Job Description

Nous recherchons un(e) Concepteur de Systèmes pour diriger les activités de conception de systèmes qui lui sont confiées dans le cadre de projets d’introduction de nouveaux produits (NPI) liés aux systèmes chirurgicaux robotisés et assistés par ordinateur.

Dans ce rôle, vous serez responsable des livrables techniques liés aux exigences système, aux données d’entrée de conception, au soutien à l’architecture système, à la gestion des risques, à la vérification et à la validation, à l’ingénierie de l’utilisabilité, aux modifications de conception ainsi qu’à la documentation du dossier d’historique de conception (Design History File – DHF).

Vous travaillerez de manière autonome afin de faire progresser les fonctionnalités des produits, les sous-systèmes ou les projets qui vous seront confiés. Vous participerez également à des activités pratiques de tests et d’intégration robotiques, tout en collaborant étroitement avec des équipes de projet multidisciplinaires.

Lieu : Montréal, Québec

Mode de travail : Hybride (minimum de trois jours par semaine au bureau)

Déplacements : Jusqu’à 25 % du temps

Principales responsabilités

Diriger les activités de conception de systèmes qui vous sont confiées dans le cadre de projets NPI portant sur des systèmes chirurgicaux robotisés et assistés par ordinateur.
Définir et maintenir les exigences système et les données d’entrée de conception, en veillant à ce qu’elles soient claires, vérifiables et traçables.
Contribuer au développement de l’architecture système et aux décisions techniques associées.
Rédiger et maintenir la documentation du DHF, notamment les besoins des utilisateurs, les exigences système, les données d’entrée de conception, les matrices de traçabilité et la documentation relative aux risques.
Participer aux activités de gestion des risques, notamment aux analyses de risques telles que l’uFMEA, et contribuer à la définition de mesures d’atténuation des risques liés à la conception.
Contribuer à la planification de l’utilisabilité et aux activités d’ingénierie de l’utilisabilité.
Participer à l’élaboration des protocoles de vérification et de validation (V&V), en collaboration avec l’équipe de développement de produits.
Gérer et documenter les modifications de conception conformément aux procédures applicables.
Participer à des activités pratiques de tests et d’intégration de systèmes robotiques.
Assurer de manière autonome la réalisation des livrables techniques liés aux fonctionnalités des produits, aux sous-systèmes ou aux projets qui vous sont confiés.
Collaborer avec les équipes de R&D, d’assurance qualité (QA), cliniques et réglementaires, en communiquant clairement les informations techniques à différents interlocuteurs.
Collaborer efficacement avec les parties prenantes internes et externes.

Qualifications

Baccalauréat en ingénierie, en sciences ou dans un domaine technique connexe (p. ex. génie biomédical, informatique, génie mécanique ou génie électrique).
Un diplôme en génie biomédical constitue un atout.
Minimum de cinq (5) ans d’expérience en conception de systèmes au sein d’une organisation multidisciplinaire.
Expérience dans un environnement réglementé soumis à des exigences strictes en matière de conformité.
Expérience dans la rédaction et la mise à jour de la documentation du DHF, notamment les besoins des utilisateurs, les exigences système, les données d’entrée de conception, les matrices de traçabilité et la documentation relative aux risques.
Expérience avec Codebeamer, Windchill et/ou JIRA, ou avec des outils similaires.
Anglais requis.

Connaissances et compétences

Connaissance de la norme ISO 14971 (obligatoire).
Connaissance de la norme IEC 62366 (atout).
Capacité à contribuer aux analyses de risques (p. ex. uFMEA), à la planification de l’utilisabilité et à la définition de mesures d’atténuation des risques liés à la conception.
Capacité à définir des exigences vérifiables, à contribuer à l’élaboration des protocoles de vérification et de validation (V&V) et à assurer la traçabilité.
Excellentes capacités d’analyse et bon jugement professionnel.
Excellentes aptitudes en communication écrite et orale.
Solides compétences en collaboration avec les équipes de R&D, d’assurance qualité, cliniques et réglementaires.
Capacité à collaborer efficacement avec des interlocuteurs internes et externes.

Pourquoi nous rejoindre ?

Une communauté internationale réunissant plus de 110 nationalités différentes.
Un environnement où la confiance est au cœur de notre culture : 70 % de nos dirigeants ont débuté leur carrière à un niveau d'entrée.
Un système de formation solide avec notre Académie interne et plus de 250 modules disponibles.
Un cadre de travail dynamique qui se réunit régulièrement pour des événements internes (afterworks, team buildings, etc.).

Amaris Consulting promeut l'égalité des chances. Nous nous engageons à rassembler des personnes d'horizons divers et à créer un environnement de travail inclusif. À ce titre, nous accueillons les candidatures de toutes les personnes qualifiées, sans distinction de sexe, d'orientation sexuelle, de race, d'origine ethnique, de croyances, d'âge, de situation matrimoniale, de handicap ou de toute autre caractéristique.

English Version ----------------------------------------------------

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.)

Apply About employer

More about this job

Responsibilities

Lead assigned systems design activities for new product introduction projects involving computer-assisted surgical and robotic systems, including requirements, design inputs, architecture support, risk management, usability, and verification and validation. Maintain Design History File documentation and design changes, participate in hands-on robotic testing and integration, and collaborate with multidisciplinary teams and stakeholders.

Requirements

Requires a bachelor's degree in engineering, science, or a related technical field and at least five years of systems design experience in a multidisciplinary organization. Candidates need experience in regulated environments and Design History File documentation, familiarity with ISO 14971, and English proficiency; biomedical engineering and IEC 62366 knowledge are preferred or assets.

Skills

Systems Design
System Requirements
Design Inputs
Systems Architecture
Risk Management
uFMEA
Usability Engineering
Verification and Validation
Requirements Traceability
Robotic Testing and Integration
Design Change Management
ISO 14971
IEC 62366
Codebeamer
Windchill

Visa sponsorship

Not detected in the job text

Keywords

Systems Design
New Product Introduction
Computer-Assisted Surgery
Robotic Systems
System Requirements
Design Inputs
Systems Architecture
Design History File
Risk Management
uFMEA
ISO 14971
IEC 62366
Usability Engineering
Verification and Validation
Requirements Traceability
Design Change Management
Robotic Testing
Systems Integration
Regulatory Compliance
Codebeamer
Windchill
JIRA
R&D
Quality Assurance
Biomedical Engineering

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