Biomedical Engineering Expert Witnesses in Indiana

This highly qualified engineer has over 15 years of consumer products engineering experience. He has held many prestigious positions at such companies as Electrolux and General Electric and currently owns and is a lead engineer of a highly successful electronics design firm.

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.

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 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.