Tool / Equipment Technician (Machine Shop Team)

MONTREAL, Tool / Equipment technician, 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 ; 

• Grew its team to ~50 people;

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

Position Summary

The Tool/Equipment Manager is a critical technical role responsible for the overall management, maintenance, calibration, tracking, and security of all company tools, equipment, and controlled fixtures. This role ensures that all assets are readily available, operational, compliant with rigorous regulatory and safety standards, and utilized effectively to maximize production uptime and R&D efficiency.

Role And Responsibilities

Maintenance, Calibration (CAL), and Scheduling:

• Develop and maintain installation qualification protocols, preventive maintenance and internal calibration procedures in accordance with manufacturers' documentation.

• Perform or coordinate installation qualification, preventive maintenance, and internal calibration on equipment. 

• Develop, implement, and manage robust Preventative Maintenance schedules for our technician/operator, ensuring maximum uptime and precision.

• Coordinate the scheduling of external calibration and maintenance services, managing vendor relationships and ensuring compliance documentation is accurate and timely.

Tool Management:

• Develop, implement, and manage a robust tracking system for all assets, including cleanroom tools and controlled fixtures.

• Responsible for assigning tool numbers and managing the tool matrix for production, ensuring accurate asset tracking and location mapping.

• Oversee the procurement and vendor process for machine shop consumables and cutting tools, with a focus on optimizing quality and ensuring comprehensive documentation.
  
  

Qualifications

Education:

• Diploma or degree in a technical field (Quality, Engineering, Biomedical, Mechanical, or a related discipline) or relevant experience.

Experience & Technical Skills:

• 3-5+ years of progressive experience in tool crib management, equipment maintenance, or inventory control in a regulated technical environment (ISO).

• Demonstrated experience performing mechanical or electronic inspections in a regulated environment.

• Experience working with an electronic Quality Management System (e-QMS).

• Proficiency in using measurement equipment and knowledge in tool calibration.

• Knowledge in Preventive scheduling and equipment maintenance.

Regulatory Knowledge:

• Familiarity with regulatory standards such as ISO Medical Devices Quality Management System) and/or FDA 21 CFR 820 (Quality System Regulation) is strongly preferred.

• Prior experience in medical devices, pharmaceuticals, or aerospace is a significant asset.

Core Competencies:

• Strong attention to detail with the ability to maintain accurate and thorough records (critical for auditing and compliance).

• Strong communication and organizational skills for scheduling and vendor management.

• Proven ability to work independently with minimal supervision and manage multiple priorities effectively.

• Being able to communicate efficiently in a Bilingual environment (French / English)

Note: This job description is intended to provide a general overview of the position. It is not an exhaustive list of responsibilities, qualifications, or requirements. The employer reserves the right to modify the duties or requirements of the position as needed.