Boris Clouet
Principal Quality Engineer - Risk Manager at ONWARD Medical | Lausanne, Vaud, Switzerland
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Boris Clouet currently serves as the Principal Quality Engineer and Risk Manager at ONWARD Medical, where he leverages over a decade of experience in the medical device industry to drive excellence in risk management and quality assurance. In his role, Boris is the owner of the company’s Risk Management Process, overseeing and coordinating risk activities across multiple departments to ensure compliance with international standards such as ISO 14971, IEC 60601, and ISO 11607. His leadership has been instrumental in advancing ONWARD’s innovative solutions, notably culminating in the successful FDA De Novo clearance in 2024 for a groundbreaking non-invasive spinal cord stimulator. This achievement underscores his expertise in navigating complex regulatory pathways and his ability to align risk management strategies with stringent safety standards and usability requirements.
Boris actively contributes to FDA and MDR submission activities, ensuring that product development aligns with regulatory expectations while maintaining a focus on patient safety and device efficacy. His involvement in usability studies and adherence to safety standards demonstrates his commitment to designing devices that are not only innovative but also safe and user-friendly. With a strong foundation in design control, risk analysis, and software validation (including Plato-e1ns software), Boris ensures that all aspects of product development meet rigorous quality assurance criteria. His expertise in project management and mechanics further enhances his ability to coordinate multidisciplinary teams, streamline risk mitigation efforts, and uphold compliance throughout the product lifecycle. Boris Clouet’s strategic approach and technical acumen continue to position ONWARD Medical at the forefront of medical device innovation, emphasizing safety, efficacy, and regulatory excellence.
Principal Quality Engineer - Risk Manager at ONWARD Medical in May 2024 to Present
Senior Quality Engineer - Risk Manager at ONWARD Medical in October 2022 to May 2024
Life Sciences Advanced Consultant at Capgemini Engineering in October 2021 to September 2022
Product risk manager at B. Braun Group in September 2019 to September 2021
R&D Project Manager and Technical Lead at B. Braun Group in June 2018 to September 2021
R&D Project Manager and Technical Lead at Coloplast in November 2014 to December 2017
PHD Candidate at PGS GROUP in May 2011 to April 2014
Research And Development Engineer at PGS GROUP in May 2011 to April 2014
Research And Development Engineer at PGS GROUP in May 2010 to April 2011
Study Engineer (Trainee) at Safran Electronics & Defense in September 2009 to March 2010
Research Assistant (Trainee) at Oregon State University in August 2007 to January 2008
Laboratory Technician (Trainee) at Lappeenranta University of Technology in April 2006 to June 2006
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Université de Bordeaux, PhD, October 2026
Université de Technologie de Troyes, Dipl.-Ing, October 2026
Université de Technologie de Troyes, M.Sc., October 2026
IUT Lannion, Two-year university degree in technology, October 2026
LGT JOLIOT CURIE (RENNES), French secondary school diploma, October 2026
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Risk Management
ISO 14708
ISO 11607
U.S. Food and Drug Administration (FDA)
English
Corrective Actions
ISO 11608
ISO 14971
IEC 60601
Quality Assurance
21 CFR 820
Human Factors Engineering
Statistical Data Analysis
Veeva Vault
Project Management
Medical Device R&D
Design Control
Risk Analysis
Medical Device Regulation (MDR)
ISO 13485
Drug Delivery
Usability Engineering
Medical Device Product Development
Medical Devices
R&D
Project Planning
Plato-e1ns software
Mechanical Testing
Materials Science
Simulations
Mechanics
Finite Element Analysis
Matlab
Physics
Mechanical Analysis
Digital Image Correlation
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What is Boris Clouet email address?
Email Boris Clouet at [email protected] and [email protected]. This email is the most updated Boris Clouet's email found in 2026.
What is Boris Clouet phone number?
Boris Clouet phone number is 0673409289 and +41767783290.
How to contact Boris Clouet?
To contact Boris Clouet send an email to [email protected] or [email protected]. If you want to call Boris Clouet try calling on 0673409289 and +41767783290. (updated on April 10, 2025)
What company does Boris Clouet work for?
Boris Clouet works for ONWARD Medical
What is Boris Clouet's role at ONWARD Medical?
Boris Clouet is Principal Quality Engineer - Risk Manager
What industry does Boris Clouet work in?
Boris Clouet works in the Medical Devices industry.
Boris Clouet Email Addresses
Boris Clouet Phone Numbers
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