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| Aspect | Associate Member | Certified Member |
|---|---|---|
| Required Credentials | Typically no certification required, often an entry-level or preliminary membership | Requires specific certifications or credentials demonstrating professional competence |
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Systems Assoc Designer II
Montreal, QC • Hybrid
Full-time
Re-posted 14 days ago
Job description
Valued Team member: We are glad you are exploring new opportunities within Zimmer Biomet!
Contributes to New Product Introduction (NPI) projects for computer-assisted surgical and robotic systems, including system requirements, design inputs, design controls, risk management, verification and validation, usability engineering, Design Changes, and Design History File (DHF) documentation.
Executes defined system design work with increasing independence while supporting hands-on robotic system testing, integration, troubleshooting, and laboratory activities. This role contributes to translation of user needs and clinical workflow inputs into system requirements and design inputs, supports subsystem decomposition and interface definition, and applies growing knowledge of quality procedures, systems engineering, and Agile/SAFe-aligned development practices.
This is a hybrid role with a minimum expectation of three days per week in office
Contribue a des projets d'introduction de nouveaux produits (NPI) pour les systemes chirurgicaux et robotiques assistes par ordinateur, y compris les exigences du systeme, les donnees de conception, les controles de conception, la gestion des risques, la verification et la validation, l'ingenierie d'utilisabilite, les modifications de conception et la documentation relative au fichier d'historique de conception (DHF).
Execute le travail de conception du systeme defini avec une independance croissante tout en soutenant les tests pratiques des systemes robotiques, l'integration, le depannage et les activites de laboratoire. Ce role contribue a la traduction des besoins des utilisateurs et des flux de travail cliniques en exigences systeme et en entrees de conception, prend en charge la decomposition sous-systeme et la definition d'interfaces, et applique une connaissance croissante des procedures qualite, de l'ingenierie des systemes et d'Agile/SAFe-pratiques de developpement alignees.
Il s'agit d'un poste hybride avec une attente minimale de trois jours par semaine au bureau
NPI responsibilities:
- Develop and maintain assigned system design deliverables and traceability for NPI projects.
- Contribute to translation of user needs, intended use, clinical workflow inputs, and stakeholder inputs into system requirements and design inputs.
- Contribute to subsystem decomposition, interface definition, and architecture-related documentation with appropriate review.
- Create and update design control, risk, verification/validation, usability, Design Change, and DHF documentation with appropriate review.
- Participate in hands-on robotic system testing, integration, troubleshooting, and laboratory evaluation activities.
- Support evaluation and integration of supplier, third-party, or externally developed components, software, or technologies as assigned.
Support collaboration with Software, Hardware, Mechanical, Clinical, Quality, Regulatory Affairs, Manufacturing, Marketing, and other stakeholders.
Quality and compliance responsibilities:
- Apply applicable quality system procedures and documentation practices within the System Design discipline.
- Support issue evaluations, complaint investigations, non-conformity activities, CAPA activities, and procedure reviews as assigned.
- Ensure assigned deliverables are accurate, complete, traceable, and prepared in accordance with applicable quality procedures.
Agile and project responsibilities:
- Participate fully in Agile ceremonies, sprint planning, PI planning, reviews, retrospectives, and related team activities.
- Plan and execute assigned work with increasing independence; provide clear status updates and escalate impediments or risks.
- Advanced Associate II team members may act as Scrum Master for smaller teams or defined project scopes.
Les responsabilites du NPI:
- Elaborer et maintenir les livrables de conception systeme attribues ainsi que la tracabilite pour les projets NPI.
- Contribuer a la traduction des besoins des utilisateurs, de l'utilisation prevue, des contributions au flux de travail clinique et des contributions des parties prenantes dans les exigences du systeme et les contributions a la conception.
- Contribuer a la decomposition du sous-systeme, a la definition de l'interface et a la documentation relative a l'architecture avec une revision appropriee.
- Creer et mettre a jour le controle de la conception, les risques, la verification/validation, l'utilisabilite, la modification de la conception et la documentation DHF avec une revision appropriee.
- Participer a des activites pratiques de test, d'integration, de depannage et d'evaluation en laboratoire de systemes robotiques.
- Prendre en charge l'evaluation et l'integration des composants, logiciels ou technologies attribues aux fournisseurs, tiers ou developpes en externe.
- Soutenir la collaboration avec les services Logiciel, Materiel, Mecanique, Clinique, Qualite, Affaires reglementaires, Fabrication, Marketing et autres parties prenantes.
Les responsabilites en matiere de qualite et de conformite comprennent:
- Appliquez les procedures du systeme qualite et les pratiques de documentation applicables au sein de la discipline Conception du systeme.
- Soutenir les evaluations de problemes, les enquetes sur les plaintes, les activites de non-conformite, les activites CAPA et les examens de procedures tels qu'attribues.
- Assurez-vous que les livrables attribues sont exacts, complets, tracables et prepares conformement aux procedures de qualite applicables.
Intermediate understanding of systems engineering, medical device design controls, quality system procedures, and regulated product development.
Working knowledge of user needs, intended use, clinical workflow inputs, requirements engineering, traceability, subsystem decomposition, interfaces, and the core design control deliverables used in NPI projects.
Ability to execute assigned technical work with increasing independence while collaborating effectively within multidisciplinary teams.
Ability to communicate technical information, rationale, follow-up, status, impediments, and risks clearly.
High level of accountability, integrity, attention to detail, and openness to coaching and feedback.
Working knowledge of Microsoft Office; experience with requirements management tools, Agile tools, SolidWorks, MATLAB, Python, or C++ is an asset.
Written and spoken French is an asset.
Comprehension intermediaire de l'ingenierie des systemes, des controles de conception des dispositifs medicaux, des procedures du systeme qualite et du developpement reglemente de produits.
Connaissance pratique des besoins des utilisateurs, de l'utilisation prevue, des entrees du flux de travail clinique, de l'ingenierie des exigences, de la tracabilite, de la decomposition du sous-systeme, des interfaces et des livrables du controle de conception central utilises dans les projets NPI.
Capacite a executer un travail technique assigne avec une independance croissante tout en collaborant efficacement au sein d'equipes multidisciplinaires.
Capacite a communiquer clairement les informations techniques, la justification, le suivi, le statut, les obstacles et les risques.
Haut niveau de responsabilite, d'integrite, d'attention aux details et d'ouverture a l'accompagnement et au feedback.
Connaissance pratique de Microsoft Office ; experience avec les outils de gestion des exigences, les outils Agile, SolidWorks, MATLAB, Python ou C++ est un atout.
Le francais ecrit et parle est un atout.
Education/Experience Requirements
Bachelor's degree in engineering, science, biomedical engineering, computer engineering, mechanical engineering, electrical engineering, or a related technical field. Biomedical engineering is an asset.
Minimum 1 to 3 year of relevant engineering experience.
Experience or exposure to medical device development, robotics, software-controlled systems, or regulated industries is an asset.
Experience with 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
Exigences en matiere de formation/d'experience
Baccalaureat en ingenierie, sciences, genie biomedical, genie informatique, genie mecanique, genie electrique ou dans un domaine technique connexe. L'ingenierie biomedicale est un atout.
Minimum 1 a 3 ans d'experience pertinente en ingenierie.
L'experience ou l'exposition au developpement de dispositifs medicaux, a la robotique, aux systemes controles par logiciel ou aux industries reglementees est un atout.
Une experience avec 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
Travel Requirements
Up to 25%. Hybrid role with a minimum expectation of three days per week in office.
Exigences de voyage
Jusqu'a 25%. Poste hybride avec une attente minimale de trois jours par semaine au bureau.
EOE/M/F/Vet/Disability
Employment Type: OTHER