Steven Dion Email and Phone Number
Ingénieur mécanique sénior avec plus de 15 ans d’expérience, j’ai piloté le développement de trois générations de dispositifs médicaux et dirigé des équipes multidisciplinaires comptant jusqu’à 10 membres au sein de la compagnie Soundbite Medical que j'ai co-fondée. Mon expertise en conformité réglementaire est bien établie, englobant les normes ISO 13485, FDA 21 CFR Part 820, Santé Canada, ainsi que les directives européennes MDD/MDR. J’ai un parcours jalonné de réussites en développement de produits et en transfert technique.Mon parcours combine à la fois une solide expérience académique, entrepreneuriale et industrielle, incluant la supervision de personnes étudiantes (stagiaires) et professionnelles. Je possède également une expérience approfondie en gestion de projets complexes, couvrant toutes les étapes du cycle de vie, du prototypage au support clinique. Mes compétences incluent la gestion du cycle de vie des logiciels, la cybersécurité et l’ingénierie de l’utilisabilité. Accoutumé au travail à distance et sur différents sites, j’exploite efficacement les outils de collaboration virtuelle pour garantir une exécution fluide des projets. En tant que co-inventeur de plusieurs brevets et auteur d’articles scientifiques, je dispose d’un solide bagage en résolution de problèmes et d’une grande capacité d’adaptation dans des environnements de travail variés.
Reaction Dynamics
View- Website:
- reactiondynamics.space
- Employees:
- 38
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Quality And Compliance DirectorReaction DynamicsSherbrooke, Qc, Ca -
Co-Founder & Director Of Operations (Consoles)Soundbite Medical Solutions Inc. Jan 2023 - Nov 2024Montreal, Qc, CaOversaw 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. -
Co-Founder & Director Console SystemsSoundbite Medical Solutions Inc. May 2015 - Mar 2023Montreal, Qc, CaLed 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. -
Level I TrainerCanadian Ski Instructors' Alliance (Csia) Nov 2009 - Apr 2020Montréal, Qc, CaTrain and certify level 1 CSIA ski instructors. -
Ski Instructor Level IiiSkibromont.Com Dec 1996 - Apr 2020Bromont, Québec, Ca -
Research Professional At LocusUniversité De Sherbrooke Jan 2006 - May 2015Sherbrooke, Québec, CaDeveloped 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.
Steven Dion Education Details
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Université De SherbrookeMechanical Engineering -
Université De SherbrookeMechanical Engineering -
Université De SherbrookeMechanical Engineering (Aeronautics) -
Cégep De Saint-HyacintheSciences Pures Et Appliquées
Frequently Asked Questions about Steven Dion
What company does Steven Dion work for?
Steven Dion works for Reaction Dynamics
What is Steven Dion's role at the current company?
Steven Dion's current role is Quality and Compliance Director.
What schools did Steven Dion attend?
Steven Dion attended Université De Sherbrooke, Université De Sherbrooke, Université De Sherbrooke, Cégep De Saint-Hyacinthe.
Who are Steven Dion's colleagues?
Steven Dion's colleagues are Oscar Sanchez-Mata, Ph.d., Matt Schroeder, William Georges, Grégoire Marchetaux, Caelan Babenko, Christophe Leclerc, Ph.d, Maxime Goulet-Bourdon.
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