Valued Team member: We are glad you are exploring new opportunities within Zimmer Biomet!
What You Can Expect
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 role remains directly 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, represents the 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 lâavancement disciplinaire pour les projets dâintroduction de nouveaux produits (NPI) impliquant des systĂšmes chirurgicaux et robotiques assistĂ©s par ordinateur. Ce rĂŽle façonne la stratĂ©gie de conception du systĂšme, les normes techniques, la stratĂ©gie dâarchitecture, la cohĂ©rence entre les projets, lâefficacitĂ© du systĂšme qualitĂ© et la capacitĂ© organisationnelle au sein de la discipline de la conception du systĂšme.
Le concepteur systĂšme principal est un leader technique reconnu qui guide lâarchitecture systĂšme complexe, la stratĂ©gie des exigences, la gestion des risques, la stratĂ©gie de vĂ©rification et de validation, la stratĂ©gie dâingĂ©nierie dâutilisabilitĂ©, les modifications de conception et le fichier dâhistorique de conception (DHF). pratiques sur plusieurs projets ou plateformes. Le rĂŽle reste directement impliquĂ© dans les tests robotiques pratiques, lâintĂ©gration, le dĂ©pannage et les enquĂȘtes techniques, tout en influençant Ă©galement les pratiques dâingĂ©nierie Ă long terme.
Le concepteur systĂšme principal peut occuper des postes de direction de projet et de discipline, tels que propriĂ©taire de produit, mandataire propriĂ©taire de produit, scrum master, architecte systĂšme, PME, ou un poste Ă©quivalent de direction technique, selon les besoins du projet et de lâorganisation. Le rĂŽle encadre tous les niveaux infĂ©rieurs applicables, fait progresser lâart de la conception de systĂšmes, reprĂ©sente la discipline dans les engagements stratĂ©giques internes et externes, et contribue Ă favoriser un environnement de travail collaboratif oĂč les membres de lâĂ©quipe peuvent soulever des problĂšmes, contester les idĂ©es avec respect et rechercher activement des solutions.
Il sâagit dâun poste hybride avec une attente minimale de trois jours par semaine au bureau.
How You'll Create Impact
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.
What Makes You Stand Out
- Recognized expertise in 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 ingénierie des systÚmes pour les produits multidisciplinaires complexes, de préférence les systÚmes de dispositifs médicaux robotisés ou contrÎlés par logiciel.
- Solide connaissance des contrĂŽles de conception des dispositifs mĂ©dicaux, des besoins des utilisateurs, des entrĂ©es du flux de travail clinique, de lâingĂ©nierie des exigences, de lâarchitecture systĂšme, de la stratĂ©gie dâinterface, de la gestion des risques, de la vĂ©rification et de la validation, de lâingĂ©nierie de lâutilisabilitĂ©, de la documentation DHF et des procĂ©dures du systĂšme qualitĂ©.
- Compétences analytiques exceptionnelles, jugement technique, analyse des compromis, facilitation de la décision et capacité à simplifier des sujets complexes pour divers publics.
- CapacitĂ© Ă diriger grĂące Ă lâinfluence entre les projets, les parties prenantes, les fonctions, les sites et les niveaux organisationnels.
- Excellentes compĂ©tences en communication Ă©crite et verbale, y compris lâalignement avec les parties prenantes, la rĂ©solution des ambiguĂŻtĂ©s et la facilitation de la dĂ©cision.
- CapacitĂ© Ă soutenir les Ă©valuations des chirurgiens, les Ă©tudes dâutilisabilitĂ©, les dĂ©monstrations techniques, les tests robotiques pratiques et les activitĂ©s dâintĂ©gration de systĂšmes.
- Expérience avec Microsoft Office, les outils de gestion des exigences, les outils Agile et SolidWorks ; MATLAB, Python ou C++ est un atout.
- Le français écrit et parlé est un atout.
Your Background
- Bachelor's degree in engineering, science, biomedical engineering, computer engineering, mechanical engineering, electrical engineering, or a related technical 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
âąBaccalaurĂ©at en ingĂ©nierie, sciences, gĂ©nie biomĂ©dical, gĂ©nie informatique, gĂ©nie mĂ©canique, gĂ©nie Ă©lectrique ou dans un domaine technique connexe. LâingĂ©nierie biomĂ©dicale est un atout.
- Les études supérieures dans un domaine connexe sont préférées.
- Minimum de 7 ans dâexpĂ©rience pertinente en ingĂ©nierie.
- Démontré un leadership technique à travers plusieurs programmes, plateformes ou initiatives interfonctionnelles complexes.
- Une expĂ©rience de travail dans un secteur hautement rĂ©glementĂ© tel que les dispositifs mĂ©dicaux, lâaĂ©rospatiale, lâautomobile ou un environnement rĂ©glementĂ© similaire est un atout.
- Une expérience avec les systÚmes robotiques, les systÚmes contrÎlés par logiciel, les produits multidisciplinaires complexes, le développement aligné sur Agile/SAFe, SolidWorks, MATLAB, Python, C++, les outils de gestion des exigences ou les outils de développement Agile est un atout.
Préféré :
- Expérience dans la conception, le développement ou la vérification de systèmes de neurotechnologie, de neurochirurgie ou de neuro-navigation
Travel Expectations
JusquâĂ 25 %. Poste hybride avec une attente minimale de trois jours par semaine au bureau
EOE/M/F/Vet/Disability