Systems Assoc Designer II
- Montreal, QC, Canada
Full-time
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Job details
- Job type
- Full-time
- Apply by
- Experience
- Minimum 1 to 3 year of relevant engineering experience.
- Posting language
- English
- Posted
Original job description
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
What You Can Expect
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.
How You'll Create Impact
NPI responsibilities include:
Up to 20% travel
This role is a hybrid position with a expecttion of being in the office 3 days a week.
EOE/M/F/Vet/Disability
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
What You Can Expect
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.
How You'll Create Impact
NPI responsibilities include:
- 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.
- 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.
- 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.
- Support Associate I team members through peer coaching and knowledge sharing.
- 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.
- 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.
Up to 20% travel
This role is a hybrid position with a expecttion of being in the office 3 days a week.
EOE/M/F/Vet/Disability
More about this job
Responsibilities
Develop and maintain system design deliverables and traceability for new product introduction projects, including requirements, design controls, risk, verification and validation, usability, and design history documentation. Participate in robotic system testing, integration, troubleshooting, quality activities, and Agile team processes while collaborating with multidisciplinary stakeholders.
Requirements
Requires a bachelor's degree in engineering, science, biomedical engineering, computer engineering, mechanical engineering, electrical engineering, or a related technical field, and one to three years of relevant engineering experience. Candidates should have intermediate systems engineering and medical device design control knowledge; experience with medical devices, robotics, regulated industries, or tools such as SolidWorks, MATLAB, Python, C++, requirements management, or Agile platforms is an asset.
Skills
- Systems Engineering
- Medical Device Design Controls
- Requirements Engineering
- Traceability
- Subsystem Decomposition
- Interface Definition
- Risk Management
- Verification and Validation
- Usability Engineering
- Robotic System Testing
- System Integration
- Troubleshooting
- Agile and SAFe
- Quality System Procedures
- Technical Communication
- Microsoft Office
Benefits
- Employee Resource Groups
- Flexible Working Environment
- Competitive Total Rewards
- Wellness Incentives
- Recognition and Performance Awards
Visa sponsorship
Not detected in the job text
Categories
- Engineering
- Healthcare
- Manufacturing
- Technology
Keywords
- New Product Introduction
- Computer-Assisted Surgery
- Robotic Systems
- Systems Engineering
- System Requirements
- Design Inputs
- Design Controls
- Risk Management
- Verification and Validation
- Usability Engineering
- Design History File
- Requirements Traceability
- Subsystem Decomposition
- Interface Definition
- System Integration
- Medical Device Development
- Quality Systems
- CAPA
- Non-Conformity
- Agile
- SAFe
- Scrum Master
- PI Planning
- SolidWorks
- MATLAB
- Python
- C++
- Requirements Management Tools
- Clinical Workflow
- Supplier Integration