Adecco is currently hiring a
System Designer for a full-time contract opportunity in
Montreal, QC. This role is ideal for an experienced engineering professional with a strong background in system design, product development, and regulatory compliance within highly regulated environments. If you have experience supporting Software as a Medical Device (SaMD) products and enjoy collaborating with cross-functional teams to drive product quality and compliance, this could be an excellent opportunity to advance your career.
In this role, you will play a key part in an accelerated product remediation initiative, supporting the refinement of existing product documentation while ensuring ongoing regulatory compliance. You will work closely with R&D, Quality Assurance, Clinical, and Regulatory teams to maintain traceability, support risk analysis activities, and contribute to the development of compliant medical device products.
- Salary: $69.00/hour
- Location: Montreal, QC
- Schedule: Monday to Friday, 8:30 AM - 5:00 PM
- Employment Type: Full-Time | Temporary
- Vacancy Status: This posting is for an existing vacancy.
Responsibilities- Support system design activities within a multidisciplinary product development environment.
- Draft, review, and maintain Design History File (DHF) documentation, including user needs, system requirements, design inputs, traceability matrices, and risk management documentation.
- Ensure documentation remains aligned with regulatory requirements and internal quality standards.
- Participate in product remediation initiatives to strengthen compliance and documentation practices.
- Support risk analysis activities, including uFMEA and other risk management processes.
- Contribute to usability planning and design mitigation strategies.
- Define and document testable requirements for product development activities.
- Support verification and validation (V&V) protocol development and execution.
- Maintain design traceability throughout the product lifecycle in collaboration with Product Development teams.
- Collaborate with R&D, Quality Assurance, Clinical, and Regulatory Affairs teams to ensure alignment across project deliverables.
- Translate complex technical information into clear, actionable documentation for various stakeholders.
- Support regulatory compliance initiatives and ensure adherence to industry standards and best practices.
- Participate in design reviews, risk assessments, and continuous improvement activities.
- Utilize tools such as Codebeamer, JIRA, or similar platforms to support documentation and project activities.
Qualifications- Must be legally eligible to work and reside in Canada.
- Bachelor's degree in Engineering, Biomedical Engineering, Science, or a related field.
- Minimum 5 years of experience in system design and product development.
- Experience working within a regulated industry environment with strict compliance requirements.
- Direct experience with Software as a Medical Device (SaMD) concepts is required.
- Strong experience drafting and maintaining Design History File (DHF) documentation.
- Experience developing and maintaining traceability matrices, user needs, system requirements, design inputs, and risk documentation.
- Familiarity with ISO 14971 risk management standards is required.
- Knowledge of IEC 62366 usability engineering standards is considered an asset.
- Experience supporting risk analysis activities such as uFMEA.
- Ability to define testable requirements and support verification and validation activities.
- Strong understanding of design controls and regulatory documentation requirements.
- Experience working with Codebeamer, JIRA, or similar lifecycle management tools.
- Strong analytical thinking and problem-solving abilities.
- Excellent verbal and written communication skills.
- Ability to effectively collaborate with internal and external stakeholders.
- Strong organizational skills with exceptional attention to detail.
- Experience working collaboratively across R&D, QA, Clinical, and Regulatory functions.
Why Apply- Competitive hourly compensation.
- Opportunity to work on innovative medical device and software-based healthcare products.
- Gain experience supporting critical product remediation and compliance initiatives.
- Collaborative and multidisciplinary team environment.
- Exposure to regulatory and quality systems within a highly regulated industry.
- Opportunity to work alongside experienced engineering, quality, and regulatory professionals.
- Professional development and growth opportunities within a cutting-edge sector.
Interested in this position? Apply now! Our dynamic recruitment team is ready to welcome you and support you on your path to success.
At Adecco, our purpose is simple: to make the future work for everyone. We live our values - Passion, Collaboration, Inclusion, Courage, and Customer-Centricity - by fostering a workplace where diversity is celebrated and every voice matters. We encourage applications from people of all backgrounds and identities. Together, we are shaping a future that works for everyone.
If you would like to learn more about Aspire Academy to enhance your skills for your next role, feel free to ask!
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