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Catherine FELIX-FAURE

Saint-Herblain

En résumé

Manage innovative projects in the medical devices field (drug preparation and/or administration) with cross-functional teams in a worldwide environment: define and follow up planning, resources, deliverables, and budget accordingly.

As a member of steering committees participate in the development of marketing and sales strategy


Team management
Conduct and challenge R&D activities
Assess upfront concepts identification with strategic marketing
Implement design control, quality and regulatory standard
Assess product development with industrial capabilities
Quality auditor , process owner of operational management and design control (ISO13485)

Action oriented
Customer focus
Driving for results


Mes compétences :
Team management
ISO13485
Pharmaceutical industry
Project management
Product and process validation
Six sigma
Product Design
21CFR820
MEDICAL DEVICES

Entreprises

  • EVEON - Project Director

    Saint-Herblain 2011 - maintenant Eveon is a pioneer in the design of automatic and completely secure injection medical devices (based on micro pumps and MEMS technologies).

    Lead all customers and internals projects: start from understanding customers’ needs and end up with customized medical device

    Manage a team of 5 engineers in different technical areas (mechanical, micro fluidic and mechatronics)

    As a member of steering committees participate in the development of marketing and sales strategy

    Quality auditor, operational management and design control quality process owner

  • EVEON - Project manager / Chef de projets

    Saint-Herblain 2010 - 2011 EVEON (France): Eveon is a pioneer in the design of automatic and completely secure injection medical devices (based on micro pumps and MEMS technologies).

    Project manager
    In charge of integrating innovative concept and developing product that meet customers’ needs (Pharmaceutical compagnies)

  • Becton Dickinson - R&D Project Manager

    Le Pont de Claix 1996 - 2010 In charge of developing new medical devices for pharmaceutical companies (injection and nasal administration)


    - Ensure follow up and ongoing commitment, from feasibility phases up to product launch (phase gate project, PACE, NPP, GPDS)

    - Develop partnership with customers, suppliers and interdisciplinary team

    - Lead meetings, interface with cross-functional organization

    - Manage operators and techniciens

    - Report for project status to operating comity (design review, risk analysis, recommendations)

    - Plan and manage project activities : define deliverables, mile stones, resources and budget accordingly

    R&D activities:

    Translate customer needs into products requirements
    Define and valide specifications, implement Design control
    Develop creative and novel technical solution
    Identify concepts and develop prototypes
    Implement and lead root cause analysis using different methods(5M, 6 sigma), use statistical tool and design of experiment
    Provide support to product industrialization

    Quality activities :

    Define quality product performance via defect rate and Cpk
    Implement design control procedure (standard ISO 13485 / 21 CFR part 820)
    Collaborate to manufacturing process qualification, following the pharmaceutical Good Manufacturing Practice (cGMP), QI QO QP
    Contribute to product and process risk analysis

    Achievement:

    Offer to end user higher performance syringes (PFS) :
    Develop syringe tip cap in TPE specific material combine with thin wall needle for injection ease and pain relieve
    Provided added features for BD Hypak* syringe: tamper evidence option, easy opening cap, safety, easy handling kit: mainly plastic injected parts, 20 up to 100 millions per year on market
    Developed totally new products (>5 patents) or concepts

Formations

  • Institut National Polytechnique

    Grenoble 2000 - 2006 matériaux métalliques

    cursus CNAM INPG formation continue

  • Coventry University (Coventry)

    Coventry 1987 - 1989

  • IUT Jean Monnet (Saint Etienne)

    Saint Etienne 1985 - 1987 techniques instrumental

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