Mathilde - Product Owner AGILE XP

Ref : 220225B002
Photo de Mathilde, Product Owner AGILE XP
Compétences
Expériences professionnelles
  • Verification and Validation Engineer

    Yoga trek and Yoga Teacher trainingResmed Paris, France
    Jan 2018 - Jan 2019

    As a team member of an international cross-functional team (Paris, Munich, Sydney; 30 people), I
    specify, develop and perform Verification & Validation tests, maintain documentation (Design History
    File).
    ● I interact effectively with the R&D team and other areas of the business including marketing,
    manufacturing, clinical and regulatory affairs to ensure the products being developed are appropriate and
    satisfy all necessary requirements.
    ● Working within regulatory requirements such as FDA guidance, IEC 60601-1, IEC 80601-2-12.

  • Digital Health – Owner of Opale DM (consulting company)
    Jan 2017 - aujourd'hui

    In the last 5 years, I performed more than 20 projects and I have audited +15 Medtech companies
    based in Paris, Rennes, Orléans, Melbourne, USA …
    ● North America Go-to-market strategy for Industrial robots (Autonomous Mobile Robots) & Interim Project
    Management
    ● Captronic trainer for minimum viable project plan for CE mark and IEC 62304
    ● In charge to implement Software Project Management tools and guidelines for a team a 18 internal
    Medical Device Engineer
    employee and Key Software Suppliers (35p) in a Lean-Agile Framework
    ● In charge to define regulatory and go to market strategy for a neurotech App (Software as a medical
    device).
    ● Mentoring of two junior Clinical Project Managers and implementation of the ISO 14155 inside the existing
    pharma-grade clinical SOPs.
    ● QMS (ISO 13485) and regulatory consulting for a small dental Manufacturer (Melbourne)
    ● Interim Field Service Manager (3 months) Management of 2 field service technician for the maintenance
    of Rehabilitation robotics (Sport Medicine).
    ● FDA Strategy proposal, Medical connected Insoles (wearables) for neurological gait monitoring.
    ● Product certification Lead (ISO 80601-2-61, IEC 60601-1 ed.3.1, IEC 60601-1-11, IEC 62304, IEC 62366-
    1, ISO 14971, RED directives, FCC part 15, IEC 60601-1-2) for a medical wearable with internal team and
    external testing laboratories. I am responsible for obtaining a class IIa CE certificate, and a 510k early
    submission.
    ● Updates of Files for IEC 60601-1 ed3.1, that imply a deep review of IEC 62366 and IEC 62304 practices
    for the product development team. I also IEC 60825-1 (laser) CB certification and the new IEC 60601-1-2
    (EMC) ed. 4 certifications. Manufacturer of surgical light. I was the technical leader for UL follow-up audit
    ● Responsible for obtaining two CE Certificates for intestinal stents and Intragastrical balloons (class IIb).

  • R&D and Engineering Project Manager In Co-Op Part Time Program) In’tech Medical, Rang Du Fliers, France
    Jan 2013 - Jan 2013

    new design of surgical instruments (CAD Solidworks)
    ● - specify, design and perform mechanical tests Finite Element Analysis on Solidworks Professional
    ● -project management (according FDA QSR requirements: 21CFR820 and 510k ), risk management
    ● - determination of input datas from biomechanics scientific literature (spine surgery).

Études et formations
  • Management (BSCM)
    Skills Summary (FDA 21CFR820 approach)
    Project Management -NPD Define regulatory, clinical and testing strategy. Coordination of
    multi-disciplinary team, Maintain project planning and DHF
    Project Management -Sustaining Manage design change by maintaining DHF, risk analysis, and
    update certification/ Product validation according new standards
    revision and new regulations.
    Product Certification &
    Validation – Design Assurance
    Lead certification project for electro-medical device with third-party
    labs.
    Industrialization - NPI Design Transfer, Process Validation, QI/QO/QP. Master Validation
    Plan, gage R&R
    Industrialization – Supplier
    development
    Supplier Audit (Lead Auditor training). I can prepare supplier quality
    agreement with strategic suppliers before review by a lawyer
    Mechanical Design CAD Solidworks, Finite Element Analysis

Autres compétences
Management (BSCM)
Skills Summary (FDA 21CFR820 approach)
Project Management -NPD Define regulatory, clinical and testing strategy. Coordination of
multi-disciplinary team, Maintain project planning and DHF
Project Management -Sustaining Manage design change by maintaining DHF, risk analysis, and
update certification/ Product validation according new standards
revision and new regulations.
Product Certification &
Validation – Design Assurance
Lead certification project for electro-medical device with third-party
labs.
Industrialization - NPI Design Transfer, Process Validation, QI/QO/QP. Master Validation
Plan, gage R&R
Industrialization – Supplier
development
Supplier Audit (Lead Auditor training). I can prepare supplier quality
agreement with strategic suppliers before review by a lawyer
Mechanical Design CAD Solidworks, Finite Element Analysis

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