Paris, Île-de-France, France
✦ PhD-Engineer working in the sector of innovative digital tools to transform the Medtech industry. Oriented towards usage value of the technologies, I am driven by problem solving to transform product concepts into realities.
★ Product vision and strategy ownership ✩ ALM/PLM and eQMS products development prioritization ✩ AI-empowerment strategy definition from scratch ✩ Group product portfolio roadmaps coordination (4 products) ✩ Supervision (Product Management and Design, AI Engineering)
★ Product delivery organization management ✩ Organization design (matrix approach) ✩ Supervision (UX/UI Design, Software/Platform Engineering, Product, QA Engineering, Program Management and IT support) ★ Program portfolio global supervision ✩ 15 business development or internal projects in 5 therapeutical areas - minimum duration of 3 years ✩ Project good practices development ★ Delivery of SaMD Technical File documentation ✩ Successful initial CE marking of a class IIa device under UE MDR with no major NC ✩ Ownership and support of production and IT QMS processes during quality audits ★ Ownership of Cybersecurity Management and Cybersecurity Manager role ✩ Development and deployment of cybersecurity processes and training in collaboration with RAQA and Data Protection team. ✩ Ownership of product and QMS cybersecurity strategy and technical documentation (implementation of IEC 81001-1-5).
★ Development of smartphone-based apps using digital biomarkers to address chronic diseases follow-up (neuromuscular diseases, genetic diseases, cardiac rehabilitation...) during clinical studies or real life (software as a medical device) ✩ Definition of products roadmaps ✩ Design and development in Agile scheme, in compliance with IEC 62304 and ISO 13485 ✩ Technical files management ★ Management of a team of Product Owners, Product Managers and Q/A Engineer
★ Project Manager and system engineer of ArtificiaI Intelligence-based (Machine Learning) products development to support Customers medical needs. Planning over the complete lifecycle from User needs definition to technical implementation, validation and regulatory clearance. Coordination of technical, regulatory, marketing and scientific activities and teams. ★ Global system design activities coordination, technological de-risking, performance issues solving
★ System hardware design management and planning with V-cycle methods (Class II medical device) ★ Verification and Validation of medical devices (Design and implementation) ★ Certification management of medical devices according to IEC 60601-1 and collateral standards, and conformity to Radio regulations for WLAN (RED, FCC...) ★ Environmental testing (climatic, transport, thermal, acoustic tests...) ★ Technical documentation for regulatory authorities (FDA, CE technical file...)
★ Comprehensive design and metrological study of DFB laser diodes modules in the NIR for high performance industrial atomic clock systems (Laser cavity and optical guides, PN-junction structure, optical grating, packaging...). Modeling of components performances in the host clock system
★ Global planner of the move of touchy industrial activities ✩ Production of a turnkey planning that minimizes industrial risks on the technological process and the production of optical instruments