System Design Specialist

Come Join the THORASYS Team!

THORASYS is a dynamic health-tech company located in Montreal’s vibrant Mile-Ex neighbourhood. We design, manufacture, and market cutting-edge medical technologies that bring new approaches to diagnosing and monitoring lung diseases such as asthma and COPD. Our mission is to revolutionize pulmonary medicine through innovative, accessible solutions that enhance patient care worldwide.

Join THORASYS and become part of our rapidly growing, multicultural team of passionate specialists and visionaries. If you are ambitious, solution-oriented, and have an entrepreneurial mindset, you’ll fit right in! Contribute to creating game-changing technologies that serve a noble purpose: making lung function testing easier and more accessible, improving the well-being of millions of patients globally. Our solutions aim to reduce emergency visits, hospitalization rates, and healthcare costs. We are looking for talented individuals to join us on this meaningful journey.

About the Role

We are looking for a biomedical engineer degree with experience and a high interest in medical devices.

This role is ideal for someone who has built solid technical foundations and is eager to apply that experience with increasing autonomy in the medical device industry, with a focus on ensuring a system level approach (encompassing seamlessly integrated software, firmware and hardware) in development projects and validating usability with end-users for pulmonary function devices.

As part of our R&D team, you will work under the supervision of the Vice-President R&D.

System Design Specialist

In this position, you will:

• Transform commercial needs into technical requirements during the scoping efforts for projects;
• Build an exhaustive list of software, performance, integration and usability testing, connecting with external test houses as needed.  Determine quantity of samples needed for each test and document in the design and development plan for the project.  Build or source samples and test jigs;
• Coordinate and perform functionality/usability tests with internal and external subject matter experts;
• Conduct risk analysis to evaluate clinical workflows and troubleshoot problems to optimize healthcare delivery, ensuring that medical devices meet regulatory standards and safety requirements
• Monitor the progress of all required DHF documents and advise the project manager of any delivery risks to the project related to documentation timelines or other challenges. Participate in the preparation and approval of these documents, including but not limited to the design and development plan, as well as usability protocols and reports.

As for all THORASYS employees, your position may include a limited amount of administrative duties.

Requirements:

University degree in Biomedical Engineering with 3–7 years of medical device experience with:

• Strong technical and scientific writing skills
• Strong written and verbal communication, and comfortable working in a cross-functional team
• Bilingual (French and English are essential), other languages are an asset
• Autonomy and self-starter required
• Thoroughness in planning and documentation
• Organized, thorough and with an eye for fine detail
• Must be able to travel up to 25% of the time
• Familiarity with regulatory environment e.g. ISO 13485, ISO 14971, IEC 60601

Nice to haves:

• Master’s Degree in life sciences/engineering;
• Knowledge of respiratory mechanics.