System Designer

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.

Advantages
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.

Responsibilities
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.

Qualifications
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%).

Our client operates in Canada. The company takes all reasonable steps to limit the number of positions in Quebec that require knowledge of a language other than French, and only requires it when necessary and its existing bilingual employees are unable to perform these duties. Based on an assessment conducted by our client, it has been determined that this position requires candidates to be fluent in English (both spoken and written). In particular, this position will require the employee to interact with centralized internal departments (e.g., Operations / HR / Finance / Legal / Contracts / Sales) that support the organization in Canada and that do not speak French.

Summary
Location: Montreal (Hybrid/On-site)

Duration: Permanent / Full-Time

Industry: Medical Device Manufacturing

Randstad Canada is committed to fostering a workforce reflective of all peoples of Canada. As a result, we are committed to developing and implementing strategies to increase the equity, diversity and inclusion within the workplace by examining our internal policies, practices, and systems throughout the entire lifecycle of our workforce, including its recruitment, retention and advancement for all employees. In addition to our deep commitment to respecting human rights, we are dedicated to positive actions to affect change to ensure everyone has full participation in the workforce free from any barriers, systemic or otherwise, especially equity-seeking groups who are usually underrepresented in Canada's workforce, including those who identify as women or non-binary/gender non-conforming; Indigenous or Aboriginal Peoples; persons with disabilities (visible or invisible) and; members of visible minorities, racialized groups and the LGBTQ2+ community.

Randstad Canada is committed to creating and maintaining an inclusive and accessible workplace for all its candidates and employees by supporting their accessibility and accommodation needs throughout the employment lifecycle. We ask that all job applications please identify any accommodation requirements by sending an email to accessibility@randstad.ca to ensure their ability to fully participate in the interview process.