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Responsible for principal-level technical leadership and discipline advancement for New Product Introduction (NPI) projects involving computer-assisted surgical and robotic systems. This role shapes system design strategy, technical standards, architecture strategy, cross-project consistency, quality-system effectiveness, and organizational capability within the System Design discipline.

The Principal Systems Designer is a recognized technical leader who guides complex system architecture, requirements strategy, risk management, verification and validation strategy, usability engineering strategy, Design Changes, and Design History File (DHF) practices across multiple projects or platforms. The roleremainsdirectly engaged in hands-on robotic testing, integration, troubleshooting, and technical investigations while also influencing long-term engineering practices.

The Principal Systems Designer may serve in project and discipline leadership roles such as Product Owner, Product Owner Proxy, Scrum Master, system architect, SME, or equivalent technical leadership role as required by project and organizational needs. The role mentors all applicable lower levels, advances the System Design craft,representsthe discipline in strategic internal and external engagements, and helps foster a collaborative work environment where team members can raise issues, challenge ideas respectfully, and actively seek solutions.

This is a hybrid role with a minimum expectation of three days per week in office

Responsable du leadership technique de niveau principal et de l'avancement disciplinaire pour les projets d'introduction de nouveaux produits (NPI) impliquant des systemes chirurgicaux et robotiques assistes par ordinateur. Ce role faconne la strategie de conception du systeme, les normes techniques, la strategie d'architecture, la coherence entre les projets, l'efficacite du systeme qualite et la capacite organisationnelle au sein de la discipline de la conception du systeme.

Le concepteur systeme principal est un leader technique reconnu qui guide l'architecture systeme complexe, la strategie des exigences, la gestion des risques, la strategie de verification et de validation, la strategie d'ingenierie d'utilisabilite, les modifications de conception et le fichier d'historique de conception (DHF). pratiques sur plusieurs projets ou plateformes. Le role reste directement implique dans les tests robotiques pratiques, l'integration, le depannage et les enquetes techniques, tout en influencant egalement les pratiques d'ingenierie a long terme.

Le concepteur systeme principal peut occuper des postes de direction de projet et de discipline, tels que proprietaire de produit, mandataire proprietaire de produit, scrum master, architecte systeme, PME, ou un poste equivalent de direction technique, selon les besoins du projet et de l'organisation. Le role encadre tous les niveaux inferieurs applicables, fait progresser l'art de la conception de systemes, represente la discipline dans les engagements strategiques internes et externes, et contribue a favoriser un environnement de travail collaboratif ou les membres de l'equipe peuvent soulever des problemes, contester les idees avec respect et rechercher activement des solutions.

Il s'agit d'un poste hybride avec une attente minimale de trois jours par semaine au bureau.

NPI responsibilities include:

• Lead complex system design activities for NPI projects, including user needs strategy, requirements, architecture, risk management, V&V strategy, usability, Design Changes, and DHF documentation.
• Influence user needs strategy and ensure end-to-end traceability and system-level alignment from user needs and clinical workflow inputs through requirements, design inputs, verification, validation, and risk controls.
• Lead architecture definition, interface strategy, system trade studies, integration strategy, and major technical decision records for complex products or project scopes.
• Lead technical interactions during surgeon evaluations, customer feedback assessments, usability studies, system demonstrations, and clinical evaluations as assigned.
• Lead or support hands-on robotic system testing, integration, troubleshooting, root cause investigations, usability evaluations, and verification activities.
• Lead evaluation and system-level integration of supplier components, third-party technologies, externally developed software, or externally developed subsystems.
• Coordinate technical activities with cross-functional stakeholders and serve as an independent reviewer for significant deliverables.

Quality and compliance responsibilities include:

• Lead or own quality-related technical investigations, including issue evaluations, complaints, non-conformities, and CAPAs.
• Improve procedures, design controls, engineering documentation, DHF quality, audit readiness, and decision rationale practices.
• Promote compliance with applicable procedures, regulatory expectations, and sound engineering judgment.

Agile and project responsibilities include:

• Drive project outcomes with minimal supervision while managing priorities, dependencies, technical risks, and stakeholder expectations.
• Resolve ambiguity, remove impediments, and support Agile/SAFe-aligned planning and continuous improvement.
• Establish technical rationale, lead trade studies, evaluate competing solutions, and document system-level decisions using sound systems engineering principles.

Leadership and mentorship responsibilities include:

• Mentor and coach lower-level Systems Designers on System Design practices, tools, and procedures.
• Advance the System Design craft through best practices, training, lessons learned, and process improvements.
• Influence practices across multiple project teams and support harmonization of System Design methods where appropriate.
• Model clear communication, accountability, constructive challenge, knowledge sharing, and respectful collaboration.

• Recognizedexpertisein systems engineering for complex multidisciplinary products, preferably robotic or software-controlled medical device systems.
• Strong knowledge of medical device design controls, user needs, clinical workflow inputs, requirements engineering, system architecture, interface strategy, risk management, verification and validation, usability engineering, DHF documentation, and quality system procedures.
• Exceptional analytical skills, technical judgment, trade-off analysis, decision facilitation, and ability to simplify complex topics for diverse audiences.
• Ability to lead through influence across projects, stakeholders, functions, sites, and organizational levels.
• Excellent written and verbal communication skills, including stakeholder alignment, ambiguity resolution, and decision facilitation.
• Ability to support surgeon evaluations, usability studies, technical demonstrations, hands-on robotic testing, and system integration activities.
• Experience with Microsoft Office, requirements management tools, Agile tools, and SolidWorks; MATLAB, Python, or C++ is an asset.
• Written and spoken French is an asset.

Expertise reconnue en ingenierie des systemes pour les produits multidisciplinaires complexes, de preference les systemes de dispositifs medicaux robotises ou controles par logiciel.
Solide connaissance des controles de conception des dispositifs medicaux, des besoins des utilisateurs, des entrees du flux de travail clinique, de l'ingenierie des exigences, de l'architecture systeme, de la strategie d'interface, de la gestion des risques, de la verification et de la validation, de l'ingenierie de l'utilisabilite, de la documentation DHF et des procedures du systeme qualite.
Competences analytiques exceptionnelles, jugement technique, analyse des compromis, facilitation de la decision et capacite a simplifier des sujets complexes pour divers publics.
Capacite a diriger grace a l'influence entre les projets, les parties prenantes, les fonctions, les sites et les niveaux organisationnels.
Excellentes competences en communication ecrite et verbale, y compris l'alignement avec les parties prenantes, la resolution des ambiguites et la facilitation de la decision.
Capacite a soutenir les evaluations des chirurgiens, les etudes d'utilisabilite, les demonstrations techniques, les tests robotiques pratiques et les activites d'integration de systemes.
Experience avec Microsoft Office, les outils de gestion des exigences, les outils Agile et SolidWorks ; MATLAB, Python ou C++ est un atout.
Le francais ecrit et parle est un atout.

• Bachelor's degree in engineering, science, biomedical engineering, computer engineering, mechanical engineering, electrical engineering, ora relatedtechnical field. Biomedical engineering is an asset.
• Graduate studies in a related field are preferred.
• Minimum 7 years of relevant engineering experience.
• Demonstrated technical leadership across multiple complex programs, platforms, or cross-functional initiatives.
• Experience working in a highly regulated industry such as medical devices, aerospace, automotive, or a similar regulated environment is an asset.
• Experience with robotic systems, software-controlled systems, complex multidisciplinary products, Agile/SAFe-aligned development, SolidWorks, MATLAB, Python, C++, requirements management tools, or Agile development tools is an asset.

Preferred:

• Experience in the design, development, or verification of neurotechnology, neurosurgical, or neuro-navigation systems

Baccalaureat en ingenierie, sciences, genie biomedical, genie informatique, genie mecanique, genie electrique ou dans un domaine technique connexe. L'ingenierie biomedicale est un atout.
Les etudes superieures dans un domaine connexe sont preferees.
Minimum de 7 ans d'experience pertinente en ingenierie.
Demontre un leadership technique a travers plusieurs programmes, plateformes ou initiatives interfonctionnelles complexes.
Une experience de travail dans un secteur hautement reglemente tel que les dispositifs medicaux, l'aerospatiale, l'automobile ou un environnement reglemente similaire est un atout.
Une experience avec les systemes robotiques, les systemes controles par logiciel, les produits multidisciplinaires complexes, le developpement aligne sur Agile/SAFe, SolidWorks, MATLAB, Python, C++, les outils de gestion des exigences ou les outils de developpement Agile est un atout.

Prefere:

• Experience dans la conception, le developpement ou la verification de systemes de neurotechnologie, de neurochirurgie ou de neuro-navigation

Jusqu'a 25%. Poste hybride avec une attente minimale de trois jours par semaine au bureau

Salary Expectations:

$105,000-$131,000 CAD