Geneva, Geneva, Switzerland
With a decade and a half of medical device development experience and a passion for innovation, I excel at project management. My mechanical engineering background equips me to work on complex products such as 3D printed implants and minimally invasive surgical instruments. As a Project Manager at Spineart, I lead the development and integration of cutting-edge medical devices for spine surgery. I have successfully launched and managed multiple projects, such as the Perla TL MIS and 3D printed complex implants and instruments. My expertise includes conducting market and user analysis, translating technical specifications, establishing project schedules, managing multidisciplinary teams, and co-authoring documentation for regulatory compliance. I am well-versed in both American (510k) and European (MDD/MDR) regulations, as well as in quality standards and risk management. I hold a TOEIC and a C2I certification, demonstrating my proficiency in English and digital skills. My goal is to create value for Spineart and its customers by delivering innovative and safe solutions that improve patient outcomes and surgeon satisfaction.
Innovative Project Management Project Monitoring - Conducted in-depth market analysis and anticipated upcoming trends - Analysed user needs and translated them into technical specifications - Establishing the overall project schedule with the project team - Managed a multidisciplinary team: R&D, RA/QA, Quality Process, Purchasing, Marketing - Conducted regular project progress reviews, highlighting achievements and ongoing challenges Documentation and Regulatory Compliance - Analysed standards and regulations compliance - Co-authored DHF/DMR documentation (risk analysis: FMEA, engineering analysis, predicate research,…) - Compiled documentation for 510k and CE submissions Research and Development - Explored innovative concepts and built prototypes through collaboration with new partners - Organized brainstorming sessions with engineers and designers - Verified 3D models and manufacturing drawings - Updating manufacturing drawings following reviews with subcontractors - Monitoring finite element analysis (FEA) to determine worst-case scenarios and failure modes - Designed product boxes and packaging Verification and Validation - Produced prototypes for practical labs and mechanical tests - Implemented mechanical verification tests (test protocols and reports, researching test laboratories) - Prepared medical surveys and participated in practical Lab to validate the products with the end users Industrialization - Sourced sub-contractors - Explored new manufacturing processes (machining, 3D printing, re-machining, etc.) - Provided support to the QP team for process qualification, cleaning and product sterilization validation - Monitoring the production of the first batches Achievements: - Validated a portfolio of about 20 implants, 40 instruments and three tray (100+ drawings) - Participated in 2 cadaver labs – very good feedback of the surgeons on products designed
Management of the Perla TL MIS launch Achievements: - Launch of the Perla TL MIS in due course Project management for product integration Management and documentation - Technical analysis of the acquired company's portfolio to identify promising products - Creation and tracking of the integration project schedule - Managing two teams: internal (Spineart) and external (acquired company) - Collecting all technical data and documentation of products for integration - Updating documentation to meet the quality system requirements of Spineart - Integration of products into the European market: creation of the CE documentation Industrialization - Integrated and updated 50+ drawings into the PDM under Spineart requirements - Optimised the product design to decrease manufacturing cost and simplify the industrialization Achievements: European CE-marking submissions in due course
Development of implants, instruments and trays intended for the treatment of spinal pathologies, in accordance with the EU, US regulations and applicable standards for medical devices Therapy areas: - Open Surgery (Perla TL range) - Mini-invasive Surgery (Perla TL MIS range) Product Development: - Researched concepts and technical solutions to simplify the surgical technique - Produced designs and drawings on SolidWorks of new products according to the design specifications - Produced prototypes for practical labs and mechanical tests - Wrote test protocols, executed the tests and wrote the tests reports to verify the functionality and the mechanical resistance of products - Prepared medical surveys and participated in practical Lab to validate the products with the end users Product industrialization: - Sourced sub-contractors - Optimised the product design to simplify the industrialization - Monitored manufacturing monitoring of the first batches. Achievements: - Validated a portfolio of about 15 implants, 30 instruments and one tray (70+ drawings) - Authored 30+ tests protocols and tests reports - Participated in 2 cadaver labs – very good feedbacks of the surgeons on instruments designed - Developed instruments: rod inserter with controlled locking and MIS modular system - Improved 15+ instruments to be in accordance with the surgeon’s feedback
Design of the product: implants, instruments and boxes o Determination of engineering solution; o Development of implants and instruments associated; o Exchange information with suppliers about the manufacturing of the products designed; Design verification & validation o Manufacturing of prototypes for the verification and the validation of the products; o Creation of test protocols; o Setting up mechanical tests according to the protocols; o Results analysis and creation of test reports; o Collect the feedbacks of the end users (surgeons) during cadaver labs; o Analyse of these feedbacks and organization of a brainstorming with the team project about the potential improvements; Industrialization of the products o Research of subcontractors; o Manufacturing monitoring of implants and instruments designed; o Ensure the instruments’ reception (concerning the instruments designed): analysis of subcontractors’ documentation, dimensional control and functional analysis; Others o Update of the Device History Record (DHR) o Update of Design History File (DHF) o Update of Device Master Record (DMR) Results Achievement of all missions within the period prescribed by the project manager: • Deadline compliance of all missions • US Submission (510k) and European Submission (CE Marking) of all devices developed
R&D project management for urological innovative products in accordance with the European directives (MDD) and applicable standards for medical devices • Led development of new products: from design inputs to product launch • Coordinated simultaneous various complex projects • Managed multidisciplinary project teams: R&D, Marketing, Manufacturing… • Monitored the realisation of the change control activities (technical support to the Change Control unit) • Used Agile project management (creation of work plan, deadline management, resources analysis…) • Analysed complaints for Post-Market Follow Up of new products. • Co-authored DHF/DMR documentation Achievements: European and US submissions of 3 projects without undue delay
Development of a new modular screw and the associated surgical instruments to complete a posterior fixation spinal system (Ulis) • Led product development throughout the device lifecycle: product context analysis, user needs analysis, specification of the user needs, product design on SolidWorks, design verification and validation, manufacturing monitoring, complaints analysis • Authored design files (DHF/DMR) • Managed the project by engaging and coordinating the project team Achievements: European submission of all devices developed Improvement of surgical instruments • Analysed instruments mechanically and dimensionally after non-conformities were reported • Researched and implemented technical solutions to improve these instruments Achievements: Improved three flagship instruments: no major non-conformities identified after the changes
Design of a medical container used for the sterilisation, transport and use of neurosurgical implants