Biomedical Engineering Expert Witnesses in Kentucky

This highly qualified expert earned his B.S. and M.S. in Mechanical Engineering and a Ph.D. in Biomedical Engineering from Marquette University. From 1977 until 2010, he held increasingly senior roles within Baxter Healthcare Corporation, most recently serving as the Technical Director of Applied Science & Technology. He was an Adjunct Professor at Northwestern University and spent four years at Exponent before becoming an independent consultant. The expert is a registered Professional Engineer in Illinois and has received 17 U.S. patents.

This engineering expert has over 30 years of experience in the field. He earned his Bachelor of Engineering and his Master of Engineering Science in Ireland before coming to the United States while working for Bendix Commercial Vehicle Systems, where he designed electronic hardware and system software for air braked truck / trailer ABS and traction control systems. He then worked on ABS and traction control for passenger cars and subsequently started the Electronics Division at Wabash National which he led from 1998 to 2003. From 2004 until 2007, the expert worked for Dana Commercial Vehicle Systems, where he spent a year leading the development of automatic tire inflation products for commercial and military applications. Before starting his own consultancy he led the development of Traction Control, ABS and related technology for Caterpillar Inc. from 2007 to 2015. This included positioning Caterpillar as the industry leader in differential clutch based drive torque distribution and traction control for off highway vehicles. He has been granted 23 patents and is a Member of the Society of Automotive Engineers and the Institute of Electrical and Electronics Engineers.

This highly qualified expert has over a decade's experience in orthopedic trauma medical device sales in both a field capacity as well as executive, following a career in law enforcement in special operations. Extensive experience, has been in thousands of surgical procedures; and has previously conducted hundreds of criminal investigations. At DePuy Synthes, Companies of Johnson & Johnson, he managed a large territory in Orthopedic Trauma devices, providing clinical expertise and training to surgeons and hospitals regarding the proper use of the company's trauma line. He is currently the Vice President at another orthopedics device company specializing in carbon fiber trauma and oncology products. In summary, this expert has sales, compliance and sales training experience, with a Law Enforcement, Collegiate Athletics, and a military academy background.

This highly-qualified expert has extensive experience in the engineering design of buildings. His work has focused on areas such as the mechanical, electrical, and plumbing engineering design, HVAC engineering design, LEED projects, energy-efficient buildings, and architecture. He earned both his BS and MS in mechanical engineering from Purdue University. This expert is a licensed professional engineer in Illinois and Indiana and is a LEED accredited professional. He is active in his field as a member of the American Society of Heating, Refrigerating, and Air Conditioning Engineers, as well as the Chartered Institution of Building Services Engineers. He is also involved in research, having authored numerous publications throughout his career. He has formerly served as an adjunct professor of architecture at Illinois Institute of Technology and an advisor and lecturer of architecture at the University of Illinois. For 30 years, this expert was a partner at Skidmore, Ownings, and Merrill LLP. During his time with this firm, he worked on a variety of different projects across the globe, with these projects including large office buildings, academic institutions, convention centers, airports, and performing arts centers. Currently, this expert serves as a consultant for a private engineering firm in Indiana.

This highly qualified expert has more than 25 years of experience in FDA regulation of medical devices, encompassing nearly all FDA field positions. He earned his BA in biological sciences at California State University and completed MBA courses with Golden Gate University. This expert is certified in regulatory affairs and is an active member of the Regulatory Affairs Professionals Society, the American Society for Quality, and the FDA Alumni Association. Further, he has several publications and has presented both nationally and internationally on topics in his field. In his early career, this expert served as a consumer safety officer, consumer affairs officer, and representative for small businesses at the FDA. He then held several industry leadership roles, including manager of regulatory affairs at Unitek Corporation and vice president of regulatory affairs in clinical research and quality assurance at both Retroperfusion Systems Inc. and Baxter Healthcare Corporation. Additionally, this expert was a medical device specialist, a compliance officer, and the director of import operations at the FDA Los Angeles District as well as a supervisory investigator at the FDA Saint Louis Office. Currently, he is a private consultant for FDA regulated businesses in Illinois.

This expert earned a BS in Electrical Engineering Technology from Purdue University and an MBA from Butler University. He specializes in industrial products, technical sales, industrial automation, pneumatics, embedded controls, firmware, embedded systems design, real time operating systems, and industrial networks. He has worked as an electrical/design engineer throughout his career, and is currently the Founder and Technical Lead of an industrial control manufacturer.

This highly qualified expert has over 20 years of FDA experience encompassing virtually all of the FDA field positions. He also has 18 years of industry experience as a mid-level Manager and Senior Executive in clinical, regulatory, and quality in the medical device industry. He has personally designed quality systems, prepared regulatory submissions, and managed 7 multi-center clinical trials for class 3 medical devices. From 1989-1993, he was the Industry Representative on the FDA Circulatory Systems panel. Finally, he is a seasoned educator/speaker with over 250 public presentations to audiences ranging from senior executives, physicians, technical personnel, other medical personnel, major media, and the general public. Currently, he is an Industry Consultant with a leading FDA consulting corporation.