Validation and Verification Specialist

Puzzle Medical Devices Inc.; Montreal (administrative region); On-site; CAD 70,000 - 100,000; Full time

Benefits offered by this job

Medical, dental et vision

Virtual healthcare (Dialogue)

3 weeks vacation + holidays

Gym membership reimbursement

Employee referral program

Free coffee

Team events

Job summary

Puzzle Medical Devices Inc. in Montreal is seeking a Validation & Verification (V&V) Specialist to help ensure our percutaneous heart pump meets all design, risk, and regulatory requirements.

You will plan, execute, and document verification and validation activities across hardware platforms, collaborating with engineering and quality teams. The ideal candidate has a biomedical, mechanical, or electrical engineering background with 2–5 years in medical device validation, hands-on testing, and

Qualifications

• 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 with precise, complex systems.

Responsibilities

• 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 coordinate system- and component-level testing to confirm design outputs meet inputs.
• Ensure verification of risk controls defined in the risk management file with traceability to test evidence.
• Support design validation activities to confirm device needs and intended use, including simulated-use testing.
• 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.
• Support design changes, product improvements, and documentation updates across the device lifecycle.
• Ensure V&V deliverables are compliant with FDA, ISO 13485 and applicable regulations.
• Assist in preparation of technical documentation for regulatory submissions and audits.

Skills

SolidWorks

Test protocols

Data analysis

Design controls

Bilingual (FR/EN)

Risk management

Education

Bachelor’s degree in Biomedical, Mechanical, Electrical Engineering

Tools

Calibration & measurement equipment

Job description

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.