プロフィール詳細

プロジェクトを作成

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Stephane G.に依頼

United States

Technical innovator - Medical Device Executive - Product development expert

プロフィール概要

R&D executive with a Masters in Plastics Engineering and 20 years of experience in the medical device industry; worked in both large-cap medical device companies and in start-up environments. My career has progressed over the last 20 years from Project Manager to V.P./head of Department of R&D / Engineering / Product Development / Regulatory. Use business acumen and entrepreneurial mindset to identify un-met product market needs, identify necessary technology roadmap, devise implementation strategy, and drive cross-functional teams to achieve on-time and on-budget programs delivery. My expertise includes executive management, strategic business planning, funding and VCs, FDA and ISO regulation adherence, project management, vendor and contract manufacturing management.

専門分野

• ★ Medical Devices
• ★ Product Development
• ★ Regulatory Writing
• ☆ Medical Device Development
• ☆ Medical Device Regulatory Consulting
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ Medical Device Regulatory Writing
• ☆ Premarket Notification/510(k) Submission

サービス

• Writing
• Research
• Data & AI

Writing Technical Writing

Research Fact Checking, Systematic Literature Review, Secondary Data Collection

Data & AI Statistical Analysis, Algorithm Design-Non ML

職務経験

Executive & Principal consultant

Medical Device Innovation Corp.

3月 2017 - 現在

VP Product development, R&D, Engineering

Andrew Tehcnologies LLC

4月 2012 - 6月 2018

VP R&D & Engineering

Caldera Medical Inc.

2月 2008 - 6月 2011

Manager, project engineering

Synergeyes

6月 2006 - 1月 2008

R&D manager

GMP Companies

6月 2003 - 6月 2006

学歴

Ph.D. student

Syracuse University

7月 1996 - 6月 1997

MS Chemical Engineering

Syracuse University

8月 1994 - 6月 1996

MS Plastic Engineering

INSA Strasbourg (ENSAIS / EAHP)

9月 1990 - 6月 1994

認定資格

• 認定資格の詳細は未入力です。