Jean Bigoney's Email Addresses & Phone Numbers

📖 Summary

Versatile materials scientist with a birds-eye view of metals thanks to a combination of a research career in academia and cross-industry experience. Over fifty scientific publications, including book chapters. After working on processing an ultra-fine-grained nickel base superalloy, I moved on to first understanding fatigue in titanium and aluminum and then improving fatigue performance in light metals. The key was to combine mechanical surface treatments with thermal treatments in ways that weren't supposed to work but in fact delivered remarkable improvments This research was not only picked up on by manufacturers of steel suspension springs, it was rewarded with a prestigious research prize from the DFG, the basic research organization in Germany. From aerospace I ventured into biomedical in the 1990s, optimizing surface treatments to mitigate effects of wear debris in titanium endoprostheses. For twelve years I ran my own small testing and consulting business. This was like the emergency room for metal components of all kinds. Fatigue, wear, overload, corrosion, misuse, improper assembly, incoming material quality issues, problems with coatings, vague drawings, damage from rough machining - I've seen it all. I’ve had the privilege of helping clients at the product development stage, advising on optimal use of mature as well as novel materials. My involvement with biomedical implants led me to become an FDA US Agent in 2002. Soon I was providing regulatory advice as well as preparing submissions to FDA for medical devices to startups. In 2011 I started an LLC to handle this activity and became more involved with quality aspects of medical device design and manufacturing. In 2014 I achieved the Regulatory Affairs Certification of the Regulatory Affairs Professional Society. With a solid foundation in materials science and experience in aerospace, biomedical, failure analysis, manufacturing and medical devices, I thrive on complex challenges.Metallurgist @ • New product development • Improving existing products • Failure analysis • Identifying opportunities for cost savings From May 2015 to Present (8 months) Senior Metallurgist @ • Failure analysis and product development (aerospace and medical devices) From February 2014 to Present (1 year 11 months) Managing Member @ • Consulting to manufacturers and importers of FDA regulated products (primarily medical devices) • Solving metallurgical problems in FDA-regulated products • Acting as a US Agent for foreign clients, including advising on compliance to FDA regulations • Assessing regulatory pathways for startups, entrepreneurs and potential importers of FDA-regulated products • Preparing and submitting 510(k)s and Q-submissions for medical devices • SOP Auditing / Internal Auditing for compliance to 21 CFR 820 GMP From March 2011 to Present (4 years 10 months) Owner and President @ • Started new company to perform materials testing, analysis and consulting for local, regional, national and international clients. Medical device regulatory consulting was offered as a sideline. • Performed failure analyses on hundreds of metallic structural components • Provided expert witness services for approx ten cases involving insurance disputes and / or lawsuits • Carried out routine testing such as compositional analysis, hardness, microhardness, corrosion and mechanical testing • Three successful 510(k) submissions on behalf of a non-US medical device manufacturer • Consulting for a European start-up with a novel process to improve biomedical implants From June 2002 to June 2014 (12 years 1 month) Full Professor (Chair for Materials in Mechanical Engineering) @ • Hired, trained and managed team of PhD scientists, seven graduate students, six interns and nine technicians • Initiated and led ten projects on surface treatment, residual stresses, light metals, soldering and biomedical implants • Advised five doctoral students on residual stresses in titanium and high-strength spring steel, electronic packaging, mechanical behavior of notched titanium, aluminum and cast iron, and developing surface treatments for hip-implants. • Developed introductory and advanced materials engineering courses for mechanical engineering students (over 600 freshmen) • Consulting on failure analysis cases and materials issues • Provided reports as an expert witness for attorneys and courts for liability suits • Consulting/teaching abroad (SIRIM in Malaysia, unnamed market leader (OEM) in Japan) • Developed novel methods to improve surface performance of titanium as a biomedical material • Planned and carried out joint research projects with orthopedic surgeons, maxillofacial, and cardiovascular specialists • Consulted on materials issues with knee implants for medium sized enterprise • Helped launch national research program on the "Interface between Material and Biosystem"​ • Developed new course on QM including statistical methods, six sigma and kaizen http://gepris.dfg.de/gepris/person/1078218 From October 1996 to March 2002 (5 years 6 months) Munich Area, GermanyAssociate Professor (Metallic Materials) @ • Obtained grants for equipment and personnel • Set up new facilities for heat treatment, metallography, and mechanical testing • Developed and taught courses on materials for electrical engineering, metal working, and physical metallurgy From April 1995 to September 1996 (1 year 6 months) Halle-Neustadt Area, GermanySection Head (Fatigue) @ • Supervised team of seven PhD scientists and technicians • Managed research on fatigue and fracture of offshore steels and titanium aluminides • Planned projects and budgets • Planned new building for sour gas testing • Carried out research on corrosion-fatigue crack growth in low- and medium strength steels From June 1990 to March 1995 (4 years 10 months) Hamburg Area, GermanyResearch Scientist @ • Initiated and carried out research programs on titanium in offshore applications. From January 1988 to March 1995 (7 years 3 months) Hamburg Area, GermanyResearch Scientist @ Research Scientist • Planned R&D efforts in corrosion, fatigue and fracture to support strategic corporate goals • Carried out research on fatigue crack growth in titanium, aluminum and magnesium • Carried out research on corrosion in aluminum-lithium alloys • Provided technical support to development and manufacturing operations From May 1985 to November 1987 (2 years 7 months) Greater St. Louis AreaPost-doctoral Research Associate @ • Carried out research on fatigue crack growth in aluminum and titanium • Trained new PhD students From March 1983 to February 1985 (2 years) Hamburg Area, GermanySummer Intern @ • Carried out research on cavitation in superplastically deformed Al 7075 • Performed routine metallography and SEM From May 1978 to August 1978 (4 months) Greater Los Angeles AreaPh.D., Materials Science and Engineering @ Stanford University From 1980 to 1983 M.S., Materials Science and Engineering @ Stanford University From 1978 to 1980 B.S., Materials Science and Engineering @ Massachusetts Institute of Technology From 1975 to 1978 Springfield High School Jean Bigoney is skilled in: Materials Science, Failure Analysis, Metallurgy, Materials, Medical Devices, FDA, Metals, Alloys, Corrosion, Material Selection, Engineering, Heat Treatment, Design of Experiments, Root Cause Analysis, R&D