Profile

MS Jean Bigoney, PHD, RAC

Nu Device Consulting LLC

Contact Details

Nu Device Consulting LLC
210 Farmers Top
Gold Member
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Bio

By education I am a materials scientist and am an expert on a wide variety of materials, metals and processes. Most of my career was spent doing research on fatigue of aerospace materials. I've authored over fifty scientific publications and four book chapters, and was the editor of a book on surface treatment of titanium. Like many titanium metallurgists, I made the transition from aerospace to biomedical in the 1990s. Instead of optimizing surface treatments on titanium alloys to improve fatigue life, I was optimizing surface treatments to mitigate effects of wear debris.

In 2002 I returned from Germany to the US to start a metallurgical consulting business. In addition to laboratory testing services, I offer litigation support as an expert witness for metallurgical failures and patent infringement cases.

On the advice of my German colleagues I signed up as a US Agent with the FDA. One thing led to another and I found myself providing regulatory advice as well as preparing 510(k) submissions and HCPCS coding requests for companies in Germany and Canada.

In 2011 I started an LLC as a venue for the regulatory activities and expanded my client base to include US as well as non-US entities.

Both of these ventures often involve giving the client bad news. The metallurgical consulting sometimes uncovers root causes of quality issues that the customer would rather didn't exist. Similarly, conveying regulatory requirements to clients generally means telling them that can't do something they wanted to. In both cases I abide by the saying "it is what it is."

Position Title

Consultant

Education

Stanford University
Ph.D.
1980 To 1983

Stanford University
M.S.
1978 To 1980

Massachusetts Institute of Technology
B.S.
1975 To 1978

Year Entered Profession

2003

Current Organization Type

Self-employed Consultant

Job History

Nu Device Consulting LLC
Owner and Managing Member
March 2011 - present

Springfield Metallurgical Services, Inc
Owner and President
June 2002 - present

Technische Universität München
Full Professor (Chair for Materials in Mechanical Engineering)
October 1996 - March 2002

Martin Luther University Halle-Wittenberg
Associate Professor (Metallic Materials)
April 1995 - September 1996

GKSS
Section Head (Fatigue)
June 1990 - March 1995

GKSS
Research Scientist
January 1988 - March 1995

McDonnell-Douglas Research Laboratories
Research Scientist
May 1985 - November 1987

Technische Universität Hamburg-Harburg
Post-doctoral Research Associate
March 1983 - February 1985

Rockwell International Science Center
Summer Intern
May 1978 - August 1978

Regional Interests

Europe, United States

Product Interests

Biomaterials, Medical Devices