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bioMérieux
- Responsable Qualité R&D (Produits IVD Cliniques)
MARCY-L'ETOILE
2016 - maintenant
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BioMérieux
- Technical Leader
MARCY-L'ETOILE
2013 - 2015
Two roles:
- Technical Leader: Cross-functional coordination of a technical team (10 people + 2 suppliers in UK and France) to design and industrialize a mechatronic system for IVD use.
- Team Leader (since March 2014): Functional management of staff and resources directly allocated to electronics, firmware and certification activities. Deploy and reinforce specific design methods and good practices within these areas of expertise.
Common activities:
- Make and/or Approve HW design choices.
- Lead Execution of Risk Management activities and unitary testing
- Report and assess development Budget and Planning
- Assure QA/RA compliance (including ISO 13485, ISO 14971, IEC 61010 and CE marking)
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Laboratoires Galderma
- Technical Services & Project Leader, Medical Devices
2010 - 2013
Role as Medical Devices Technical leader and Technical Quality Specialist within "Manufacturing and Technical Operations" division (Medical Devices Class I, IIa, IIb).
- To manage the international After Sales Service and Complaint handling, including worldwide local repair companies in 4 continents from operational, technical and quality standpoints.
- To manage 3rd party production suppliers and to lead engineering actions related to manufacturing operations (COGS reduction, cycle time savings, process robustness, etc).
- To initiate and develop Medical Devices activities at Alby-sur-Chéran plant. Creation of technical team and laboratory.
- Definition of budget, ressources, KPIs and priorities.
- To perform technical audits. To improve the local QA process.
- To liaise with QA to maintain CE mark and FDA approval. Support during FDA and ISO audits. ISO 13485.
- To assure technical and risk management compliance (IEC 60601-1, ISO 14971) and to lead CAPA processes and Change Requests.
- To provide technical expertise to R&D and Marketing and give input to product design and user requirements.
- To lead project teams and coordinate risk assessment and engineering activities for the industrialization and life-cycle management of medical devices.
- To lead joint actions with Global Marketing in order to customize service improvement on key markets.
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Fresenius Kabi
- R&D Project Manager (Medical Devices)
Fresnes
2009 - 2010
- Multidisciplinary teams coordination and R&D projects lead from proposal to production (Medical Devices class IIa and IIb).
- To specify, review and verify R&D engineering activities according to medical devices regulatory aspects (IEC 60601-1 3rd Ed and collateral standards, CE marking, ISO quality standards, etc).
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Envoy Medical Corporation
- Field Clinical Engineer
2008 - 2009
- To participate in the clinical deployment of a new hearing restoration device (Class III).
- To step up in the operating room to assist the surgeon during the implant procedure in all the technical aspects related to the device (transducers positioning, troubleshooting, real-time data analysis, go-no-go criteria, etc.).
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CEA / Leti
- Research Engineer
GRENOBLE
2005 - 2008
- To design a processing system (signal, electronics, algorithm) over an embedded system. The goal was to prove the feasibility of a completely implantable (Class III) brain-machine interface. I proposed a new low power embedded detection and sorting scheme, which allowed a factor 1:1000 of data reduction.
Patent granted (see below).
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CEA / Leti
- R&D Engineer
GRENOBLE
2003 - 2004
To develop a wireless subcutaneous neural implant (Class III medical device) used for treating Parkison’s Disease through Deep Brain Stimulation (DBS). I developed the FPGA-based core of the implant (including the V&V process) and the development of the User Interface used by the surgeon in the operating room.
