Menu

Cécile GENEVIEVE

MONTPELLIER

En résumé

Mes compétences :
Innovation
Medical devices industry
Project management
Spine and brain surgeries
Product development
Risk analysis
Development supplier management
Team management
Medical devices regulation
Usability engineering
Industrialization
Technical studies

Entreprises

  • Medtech SAS - Clinical and risks Leader

    2014 - maintenant Clinical Specialist contributing to production definition and design by providing the voice of the customer. Validation strategy definition and management of product validation activities.
    Development of user-centered design to promote ease-of-use, reduce usability risks and take into account usability engineering principles.
    Oversight the risk management activities in design control (risk analysis, FMEA...)
    Research strategy roadmap for clinical trials and clinical publications. Management of clinical trials activities.

  • Medtech SAS - Project Manager

    2012 - 2014 Involved in Spine project since its launch. Product development, in particular in consolidation of user requirements, by analyzing operating room functionning, and neurosurgeons needs. Submission of a clinical trial application to the French authorities (ANSM & ethics committee). Establishment of clinical evidences for device safety & effectiveness

  • Medtech SAS - Quality and Regulation Affairs Manager

    2010 - 2012 Development of Quality Management System, in particular for manufacturing, R&D, customer service and sales processes. Follow-up of non-conformities/customer complaints. Submission of regulatory files for FDA and Canada Health.

  • PSA - Development Project Manager

    2005 - 2008 Project management in ressources, planning and budget. Design of new lighting systems, including projectors and rear lights and 28 other references for 2 different vehicles, 125 M€ turnover. Technical interactions with all project actors, implying skills in mechanics (injected plastic), electrical and electronic, people management and suppliers management. Developpement of a new purchasing strategy, an optimized planning in rupture, and new technical specifications for quality performance.

  • PSA - Expert Engineer

    2001 - 2005 Main expertise interface about lighting systems for development project teams, vehicle in production teams, purchasing teams and innovative teams. Set up of a global action plan to reach objectives in term of quality and customer satisfaction: transverse technical specifications, design rules and methodologies, transverse validation plan, test methodologies, supplier selection methodologies, set up of innovative projects- Two patents.

  • Sylea - Groupe Labinal - Innovative project manager

    1999 - 2001 Project management in innovative design, based on flat cables and new technology of connexions, to participate in ambitious vehicle weight and assembly time reduction. Main technical interface between all the project actors: car manufacturers (German, Spanish and French), suppliers, and internal team

  • Filtrauto- Groupe Labinal - Innovative Project Manager

    1997 - 1999 Research projects set up for product performance enhancement, and optimization of test methodologies. Creation and startup of long term research collaborations between Filtrauto and American and French universities.

Formations

Réseau

Annuaire des membres :