Steven Dion

Background

About Steven Dion

Senior Mechanical Engineer with over 15 years of experience, I have led the development of three generations of medical devices and managed multidisciplinary teams of up to 10 members at Soundbite Medical, which I co-founded. My expertise in regulatory compliance is well-established, covering ISO 13485, FDA 21 CFR Part 820, Health Canada, as well as European MDD/MDR directive and regulation. I have a track record of successful product development and technical transfer. My background combines extensive academic, entrepreneurial, and industrial experience, including the supervision of both student interns and professionals. I also have in-depth experience in managing complex projects, covering all phases of the lifecycle, from prototyping to clinical support. My skills include software lifecycle management, cybersecurity, and usability engineering. Experienced in remote work and on multiple sites, I effectively leverage virtual collaboration tools to ensure seamless project execution. As a co-inventor on several patents and author of scientific articles, I have a strong foundation in problem-solving and a high level of adaptability in diverse work environments. I recently transitioned to the aerospace industry, joining Reaction Dynamics as director of quality and compliance.