Validation and Verification Specialist

Join the Team!

Joining Puzzle Medical means becoming part of a team dedicated to improving the treatment of advanced heart failure. You’ll contribute to the development of innovative technology designed to enhance patients’ quality of life and clinical outcomes.

We offer a collaborative and dynamic MedTech environment where initiative is encouraged and ideas are valued. As a growing company, your work will have real impact and visibility, and you’ll have the opportunity to grow alongside the organization.

If you’re motivated by meaningful work and enjoy working in a hands-on, innovative setting, Puzzle Medical offers the opportunity to contribute to important advancements in patient care.

Summary

The Validation & Verification (V&V) Specialist supports the development and commercialization a percutaneous heart pump. The V&V Specialist is be responsible for planning, executing, and documenting verification and validation activities to ensure product requirements, risk controls, and regulatory expectations are met.

Responsabilities

• Develop and execute verification and validation strategies aligned with product development milestones.
• Author and maintain V&V documentation including test plans, protocols, test reports, and traceability matrices.
• Perform and/or coordinate system-level and component-level testing to confirm design outputs meet design inputs.
• Ensure verification of risk control measures defined in the risk management file and maintain strong traceability to test evidence.
• Support design validation activities to confirm the device meets needs and intended use (including simulated-use testing when applicable).
• Contribute to design reviews by providing V&V input on requirements, testability, acceptance criteria, and compliance readiness.
• Analyze test data, investigate failures, document deviations, and support troubleshooting with Engineering team.
• Support design changes, product improvements, and documentation updates throughout the device lifecycle.
• Ensure V&V deliverables are compliant with applicable regulations and standards (FDA, ISO 13485)
• Support preparation of technical documentation for regulatory submissions and audits.

Qualification & Experience

• Bachelor’s degree in Biomedical, Mechanical, Electrical Engineering, or related discipline.
• 2–5 years of experience in validation/verification, test engineering, or quality engineering in the medical industry.
• Proven experience in experimental design and setup, including work with precise and complex systems.

Knowledge & Skills

• Proficiency in SolidWorks or similar CAD tools, with a focus on mechanical design for experimental setups.
• Hands-on experience executing test protocols and generating clear technical reports.
• Analytical mindset with experience interpreting experimental data and troubleshooting setups.
• Strong understanding of design controls, regulated documentation, and risk management principles.
• Bilingual in French and English. The role requires communication with colleagues, suppliers, and regulatory organizations internationally.

At Puzzle, we value our employees and offer a comprehensive benefits package

• Comprehensive group benefits including medical, dental, and vision coverage;
• Virtual healthcare access for you and your immediate family (Dialogue)
• 2 sick days + 3 personal days to support your work-life balance;
• 50% reimbursement on gym memberships to support your well-being;
• 3 weeks of vacation + Paid holiday closure in December so you can fully enjoy the festive season;
• Employee referral bonus program;
• Free coffee to keep you energized;
• Regular team activities and social events to foster a collaborative and fun work environment.