Profile Details

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Hire Stephane G.

United States

USD 160 /hr

Technical innovator - Medical Device Executive - Product development expert

Profile Summary

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.

Subject Matter Expertise

• ★ 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

Services

• Writing
• Research
• Data & AI

Writing Technical Writing

Research Fact Checking, Systematic Literature Review, Secondary Data Collection

Data & AI Statistical Analysis, Algorithm Design-Non ML

Work Experience

Executive & Principal consultant

Medical Device Innovation Corp.

March 2017 - Present

VP Product development, R&D, Engineering

Andrew Tehcnologies LLC

April 2012 - June 2018

VP R&D & Engineering

Caldera Medical Inc.

February 2008 - June 2011

Manager, project engineering

Synergeyes

June 2006 - January 2008

R&D manager

GMP Companies

June 2003 - June 2006

Education

Ph.D. student

Syracuse University

July 1996 - June 1997

MS Chemical Engineering

Syracuse University

August 1994 - June 1996

MS Plastic Engineering

INSA Strasbourg (ENSAIS / EAHP)

September 1990 - June 1994

Certifications

• Certification details not provided.