Highlights
Responsibilities: Responsible for leading assigned system design activities within New Product Introduction (NPI) projects for computer-assisted surgical and robotic systems, including system requirements, design inputs, system architecture support, risk management, verification and validation, usability engineering, Design Changes, and Design History File (DHF) documentation. This role independently drives technical deliverables for assigned product features, subsystems, or projects, participates in hands-on robotic testing and integration activities, and collaborates across multidisciplinary project teams.
Numbers & Facts
| Location | Montreal, QC |
| Industry | Management Consulting Services |
| Salary | $47.89–$51.09 Per Hour |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | https://www.iconma.com/ |
Description
Our Client, a Medical Devices / Healthcare company, is looking for a System Designer for their Montreal, QC/Hybrid location.
Responsibilities:
Requirements:
Why Should You Apply?
Responsibilities:
- Responsible for leading assigned system design activities within New Product Introduction (NPI) projects for computer-assisted surgical and robotic systems, including system requirements, design inputs, system architecture support, risk management, verification and validation, usability engineering, Design Changes, and Design History File (DHF) documentation.
- This role independently drives technical deliverables for assigned product features, subsystems, or projects, participates in hands-on robotic testing and integration activities, and collaborates across multidisciplinary project teams.
Requirements:
- 5+ years of experience
- Strong experience in system design in a multi-disciplinary organization.
- Experience drafting and maintaining DHF (design history file) content, including user needs, system requirements, design inputs, traceability matrices, and risk documentation.
- Able to support risk analysis (e.g uFMEA etc) and contribute to usability planning and design mitigations.
- Familiarity with ISO 14971 is required, and IEC 62366 preferred.
- Ability to define testable requirements, support V&V protocol development, and ensure traceability in collaboration with the Product Development team.
- Strong collaboration skills across R&D, QA, clinical, and regulatory functions; able to clearly translate technical information across stakeholders.
- Must have experience in a regulatory environment with strict compliance.
- Strong analytical skills and accurate judgment making skills.
- Ability to deal effectively with internal and external collaborators.
- Excellent communications skills; written and verbal.
- Experience with Codebeamer, windchill, and/or JIRA, or similar.
- Bachelor's degree in engineering, science, biomedical engineering, computer engineering, mechanical engineering, electrical engineering, or a related technical field. Biomedical engineering is an asset.
Why Should You Apply?
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
Benefits
401K, Employee Referral Program, Life Insurance
About Company
ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.
- Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
- Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
- Founded in 2000
- 2000+ Employees
The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.