MONTREAL, V&V Specialist, full-time, in-person

Puzzle Medical Devices® Inc. is developing a percutaneous heart pump for patients with advanced heart failure. The device’s design allows for safe percutaneous implantation to support both renal and cardiac function through a 4 mm-pump implanted in the descending aorta with a 4 Fr axillary driveline, allowing full patient mobility. To date, Puzzle Medical Devices® Inc. has successfully:

● Completed 3 financing rounds in 2022, 2023, and 2025;

● Completed its first-in-human study with all patients experiencing improvements in cardiac and kidney function from 2022 - 2024;

● Grew its team to ~50 people;

● Received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation in 2021.

Position Summary

Puzzle Medical Devices® Inc. is currently seeking a Validation & Verification (V&V) Specialist to support the development and commercialization a percutaneous heart pump. The V&V Specialist will be responsible for planning, executing, and documenting verification and validation activities to ensure product requirements, risk controls, and regulatory expectations are met.

Role And Responsibilities

● Develop and execute verification and validation strategies aligned with product development milestones and regulatory requirements.

● 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 and user needs.

● Design, develop, and qualify test fixtures, custom tools, and experimental setups required to support verification and validation activities.

● Support calibration activities and ensure measurement systems are appropriate, controlled, and verified for accuracy and repeatability (including verification of measurement methods when applicable).

● Conduct and support cardiovascular performance testing, including Mock Circulatory Loop (MCL) testing and other hemodynamic simulation platforms.

● Participate in wetlab testing activities, including device preparation, experimental execution, and data collection under simulated-use or pre-clinical conditions.

● 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.

● 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 teams, including root cause analysis activities as required.

● 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.

Qualifications

● Bachelor’s in Mechanical, Biomedical, or related field.

● Proven experience in experimental design and setup, including work with precise and complex systems.

● Proficiency in SolidWorks or similar CAD tools, with a focus on mechanical design for experimental setups.

● Strong manual dexterity and attention to detail, with the ability to handle delicate and intricate tasks.

● Analytical mindset with experience interpreting experimental data and troubleshooting setups.

● 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.

● Strong understanding of design controls, regulated documentation, and risk management principles.

● Hands-on experience executing test protocols and generating clear technical reports.

● Excellent organization skills, attention to detail, and ability to work in a fast-paced environment.