Mathilde - Product Owner AGILE XP

Verification and Validation Engineer

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.

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).

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).