Steven Dion Email & Phone Number

Sherbrooke, Qc, Ca

Sherbrooke, Qc, Ca

Montreal, Qc, Ca

Oversaw the production process, identified and qualified suppliers, and developed solutions for managing obsolete parts and long lead times.Provided technical support during clinical cases, ensuring the correct use of the device and resolving real-time technical issues to support healthcare professionals.Contributed to the redaction of 510(k) submission files, facilitating FDA clearance and successful entry into the US market.Managed technical transfer to a partner company, facilitating integration into their manufacturing processes and ensuring compliance with local regulations.

Montreal, Qc, Ca

Led the design and development of 3 generations of class II (US) / IV (Canada) / IIa (EU) medical devices, ensuring compliance with ISO 13485 and FDA 21 CFR Part 820 regulations.Efficiently managed remote teams and projects, coordinating cross-functional groups across home office and secondary office locations to ensure successful project delivery and compliance with regulatory standards.Co-invented the Soundbite core technology, leading to many international patents (Unites States, Canada, Europe, China, Japan, India, Russia).Negotiate the awarding of contracts to external firms.Managed risk analysis processes per ISO 14971, ensuring product safety and regulatory approvals.Directed software development teams, achieving full Class-C compliance with IEC 62304 software lifecycle requirements.Ensured that product designs comply to IEC 60601 and IEC 62366-1 standards for electrical safety and usability engineering.Supported Health Canada and EU MDD/MDR submissions, focusing on timely product certification andlicensing.

Montréal, Qc, Ca

Train and certify level 1 CSIA ski instructors.

Bromont, Québec, Ca

Sherbrooke, Québec, Ca

Developed an arterial re-canalization device for chronic total occlusions, with successful demonstration of efficacy and safety in ex-vivo human arteries and animal models.Designed an extracorporeal shockwave lithotripter with an adaptive focal zone, validated for efficacy and safety in animal trials.Innovated a temporal compression method for broadband acoustic waves, contributing to advancements in acoustic wave technology.Co-developed a single-dose needleless injector for mass production, leading to US patent 9,255,665. Presented the technology at TV quiz Génial (Télé-Québec).Demonstrate the functional feasibility of a multi-dose needle-free injector prototype (original U.S. patent no. US7,320,677).Conducted a Proof-of-Concept study for the dynamic evaluation of hockey sticks in collaboration with NIKE BAUER INC., assessing performance degradation over time.Designed a portable infusion pump flow controller for RMS MEDICAL PRODUCTS.Adapt a LabVIEW programming architecture for the automation of a wheelchair ergometer; on behalf of the company Keku.

Ph.D., Mechanical Engineering

M.Sc., Mechanical Engineering

B.Eng., Mechanical Engineering (Aeronautics)

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