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System Designer

https://www.randstad.com Logo

Randstad

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Location:
Canada , Montreal

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

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Job Description:

Randstad Digital is seeking a high-caliber System Design Engineer to join a global pioneer in the medical device and pharmaceutical sector. This industry leader specializes in developing cutting-edge surgical technologies that revolutionize orthopedic care. You will join a multidisciplinary R&D team dedicated to creating high-impact products from initial concept through to global commercialization. This is a role for a hands-on technical leader who thrives in highly regulated environments and is passionate about ensuring product safety and clinical excellence.

Job Responsibility:

  • End-to-End Product Ownership: Lead the design control process from prototype initiation through to final market release
  • Requirements Engineering: Translate complex user, business, and regulatory needs into precise system specifications and technical requirements
  • Risk & Validation: Conduct rigorous product risk assessments and oversee the verification and validation (V&V) protocols to ensure absolute product reliability
  • Technical Documentation: Author and maintain comprehensive quality and design documentation in compliance with international medical standards
  • Cross-Functional Leadership: Act as a bridge between software, mechanical, and hardware teams, potentially serving as a Proxy Product Owner or Scrum Master within an Agile framework
  • Lifecycle Management: Support existing product lines, participate in usability testing with clinical stakeholders, and contribute to client training and support

Requirements:

  • Bachelor's degree in Engineering or Science (Software, Computer, Biomedical, or a related technical field)
  • 3 to 5 years of experience in R&D product development within highly regulated sectors (Medical, Aerospace, or Pharma)
  • Proven track record of taking at least one complex product through a full 2–3 year lifecycle (from napkin sketch to market)
  • Strong expertise in Risk Management (ISO 14971) and familiarity with medical standards (ISO 13485, IEC 62304, IEC 62366)
  • Proficiency with Agile tools such as Jira and Confluence
  • Ability to travel occasionally (up to 5%)
What we offer:
  • Work at the forefront of medical innovation with life-changing technology
  • Competitive compensation package within a stable, world-renowned organization
  • Dynamic Agile work environment fostering continuous improvement and professional growth
  • Collaborative culture with a focus on high-quality engineering standards
  • Modern office located in the vibrant tech hub of Montreal

Additional Information:

Job Posted:
May 16, 2026

Expiration:
June 29, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
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