Senior hardware designer - medical devices development

Our client, a young medical technology company specializing in the development of cutting-edge resuscitation technology, is currently looking for a Senior Hardware Designer.

Nature of position

Under the supervision of the Vice President and Chief Technology Officer, you will play a key role in the company’s development, notably by developing the hardware architecture and the choice of hardware and software components embedded in its latest medical device. You will act as a specialist and ensure the follow-up and efficiency of projects while contributing to the evolution of internal practices. Finally, you will have the opportunity to elevate your position as you will be responsible for building and supervising your own team. As such, you will :

• Participate in the development and design reviews of medical devices ;
• Develop low-level hardware and software architecture (firmware) ;
• Design electronic printed circuits boards (PCBs) and select electronic components ;
• Design analog and digital circuits (signal conditioning, filters, etc.) ;
• Select and build operating systems and kernels for embedded architecture ;
• Program software drivers, firmware, libraries, and executable files ;
• Define user requirements and engineering specifications refereed to applicable regulatory standards ;
• Write and develop product qualification tests and Clinical Protocols ;
• Perform electromagnetic compatibility and protective circuitry tests in a medical environment ;
• Write and execute quality assurance protocols for design validation and verification, namely unit, integration and regressive tests ;
• Globally manage inspection processes of hardware/electronic products ;
• Participate in the drafting of quality assurance documents, particularly with respect to design validation of electrical/electronic products;
• Prepare documentation in support of design history files and regulatory submissions related to the electrical design of medical devices ;
• Perform every other task compatible with your functions.

Required qualification

• Bachelor in electrical engineering , electronic engineering, or any other relevant experience ;
• Minimum of 8 to 10 years’ experience in electronic board design, preferably related to medical devices and ultrasound ;
• Demonstrated experience in electronic circuit design in a real-time signal and image processing environment ;
• Experience in embedded systems programming (DSP, FPGA, ARM, GPU) and GPU/CUDA programming ;
• Prior knowledge and experience of the regulatory environment related to the development of medical devices (ISO 13485, IEC 60601-1 and 60601-1-2, ISO 14971 CMDCAS, 21 CFR, etc.) (an asset) ;
• Rigor, initiative, autonomy, communication skills, ability to manage multiple and sometimes conflicting priorities, leadership, team management, creativity in problem solving ;
• Bilingualism in English and French (written and spoken).

Education / training

Bachelor in electrical engineering

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