Concepteur système
Listed on 2026-10-02
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Engineering
Biomedical Engineer, Systems Engineer
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MONTREAL
, System Designer (Electrical R&D Team), 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.
Puzzle Medical Devices® inc is currently seeking a System Designer with experience in the development of embedded electronic medical devices. As part of the Electrical / Systems team, you will be responsible for defining and maintaining the system architecture and requirements of our product, ensuring that electronics, firmware and software components work together safely and reliably.
ROLE AND RESPONSIBILITIES- Work with clinical, marketing, and engineering stakeholders to elicit, analyze, and document user needs and system-level requirements for the device and its accessories
- Define, document, and maintain the system architecture and interfaces between electronic, firmware, software, and mechanical components
- Decompose system-level requirements into clear, verifiable subsystem requirements, and maintain end-to-end requirements traceability
- Identify and assess technical and usability risks; contribute to formal risk management activities and ensure risk controls are reflected in requirements and design
- Collaborate with verification and validation teams to define system-level acceptance criteria, review test strategies, and support integration and troubleshooting across subsystems
- Participate in design reviews, design change impact assessments, and usability engineering activities to ensure safe, intuitive, and robust use of the system
- Bachelor’s degree in Biomedical Engineering, Electrical, Software, or related field
- Minimum 3 years of experience in medical system engineering
- Hands‑on experience in medical device development and compliance with regulatory standards
- Solid knowledge of ISO 13485 and IEC 62304; familiarity with ISO 14971 and IEC 60601 is an asset
- Strong background in hardware/firmware design verification and validation
- Excellent communication skills and ability to collaborate across multidisciplinary teams
- Proficient in both French and English, written and spoken
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