Biomedical Engineering Expert Witnesses

This Boston based expert earned his Bachelor's of Science degree in electrical engineering from Tufts University. He began his career in medical device design at Siemens Medical Systems, thereafter serving as the Director of Engineering for Aspect Medical Systems, the developer of the world's first anesthesia monitor, which is now in 90% of operating rooms worldwide, and has served at least 200 million patients. He serves on the scientific advisory boards of several medical device firms including Safe-Op Surgical, a manufacturer of intraoperative nerve monitors.

This expert in the biomechanics of the human spine earned his undergraduate degree from the University of Pennsylvania and his doctorate in biomedical engineering from Duke University, where he researched spinal trauma. In recognition of his scholarly contributions, the Orthopedic Trauma Association granted him the 'Best Paper' award for his work on spine trauma and the spine's response to loads. He has served as a reviewer for the both the 'Journal of Biomechanics' and 'Spine'. He has significant exposure to the clinical arena, having taught residents and fellows in orthopedic surgery at the Baylor College of Medicine and the Methodist Hospital in Houston, Texas. He currently applies his knowledge as a consultant.

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 medical device sales professional has been in the industry since 1999. He earned his B.A. in Economics from Emory University and eventually went to work for Boston Scientific as a Territory Sales Manager in Men's and Women's Health. After 10 years with Boston Scientific, the expert joined St. Jude Medical's Neuromodulation device team as a Territory Manager in the Gulf Coast region. He was involved in 800+ implants and worked on device servicing for an additional 200+ patients. The expert left St. Jude at the end of 2015 and is now a Business Development and Sales Manger for a different device company in a separate product category.

This expert has designed and improved over 400 machines for the food, pharmaceutical, electronics, mining, consumer goods and automotive industries. He has led major design projects for Fortune 500 Companies, such as Unilever, Coca-Cola, Nestle, Komatsu, Caterpillar, and Hitachi. He earned his Bachelor's and Master's degrees in Mechanical Engineering in Italy, and has gained considerable professional experience in the United States, having recently served as the Chief Engineer for American Conveyor.

This expert is an experienced manufacturing engineer with a solid background in 3d modeling, design, layout, and detail for products, tooling fixtures, special machinery, robotics, and conveying systems. He has held numerous senior engineering and design positions throughout his career at firms such as American Conveyor, Adaptive Manufacturing, and ABB Robotics. Currently, he is a lead project engineer at a top engineering firm.

This licensed Professional Engineer currently works as a Chemical/Mechanical Forensic Engineer for a multi-disciplined engineering and investigation company. Provides forensic and technical services to attorneys, insurance companies, independent adjusters, restoration companies, contractors, municipalities, and individuals towards the resolution of claims or litigation. Areas of Expertise: Chemical process design, mechanical equipment applications and safety controls, manufacturing, and production, including: chemical, petrochemical, polymer plastic production, refrigeration, coal, coke, steel making, material handling and pneumatic conveying; gas, dust and chemical explosions; hazardous chemical exposures; over-pressurization explosions; nuclear waste processing; water treatment; power and fuel engineering; heating, ventilating, air conditioning, and humidification, including boilers and related safety. Provided expert opinions in over 1,000 forensic cases and provided court testimony, when required. He has considerable background investigating the proximate cause of fires and/or explosions involving electrical and mechanical appliances such as stoves, dishwashers, conditioners, toasters, and others. The expert previously worked for Robson Lapina Inc.; Vice President at KMS Forensic Engineering Consultants, and as the Chief Engineer and Project Manager for A.R.C. Technologies Corporation.

This licensed engineer earned his BS in Electrical Engineering from the University of Missouri and is a certified fire & explosion investigator. He has held a number of electrical engineering and products safety positions throughout his career, specializing in EE, product development, technical management, design verification, advanced troubleshooting, and failure analysis. This expert is currently a Senior Professional Engineer at a private Engineering consultancy.

This highly credentialed biomedical engineer has significant experience in the design and development of cardiothoracic medical devices. He earned his Master's degree from Georgia Tech and the Emory University School of Medicine; After six years of industry experience he returned to academia and obtained the PhD from the University of Aarhus in Denmark. Then at the Aarhus University Hospital he achieved the Doctor Medicinae (DrMed) degree, which denotes medical research expertise above and beyond a PhD. He is an active member of several scholarly societies in the biomedical field and is a regular reviewer of the Annals of Biomedical Engineering, the Journal of Surgical Research, and Cardiovascular Engineering and Technology. He currently serves on the biomedical engineering faculty of a major Southern university.

This FDA regulation expert earned her B.S. in Environmental Chemistry from Purchase College and her M.S. in Environmental Science from the University of Colorado Denver. She began her career with the FDA in 1987 as a Chemist in the Denver Districts Laboratory and then became a Compliance Officer in 1992, specializing primarily in medical device and biologics cases. She later managed a group of eight investigators as a Supervisory Consumer Safety Officer and then became a Compliance Officer, tasked with evaluating reports and lab analysis to determine compliance with regulation. The expert finished her FDA career as a Senior Case Review Expert, a role she held from 2008 until the end of 2015. In this position, she was responsible for reviewing and evaluating proposed judicial actions to determine if they were compliant with the requirements of the the Federal Food, Drug, and Cosmetics Act and other regulations. Currently, the expert runs her own consulting business.

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 biomedical engineer specializes in materials science and biomechanics. He earned his B.S. and Ph.D. from New Jersey Institute of Technology, where he also served as a Postdoctoral Research Scientist overseeing the development and execution of experiments measuring neuronal activity after traumatic brain injuries. The expert is now an Adjunct Professor in Biomedical Engineering departments at two New Jersey higher education institutions.

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 qualified expert of Hospital Procurement obtained his AA from Enterprise State Community College and his BS from Troy State University. He is a certified Pharmacy Technician, Licensed Practical Nurse, and an Emergency Medical Technician. He is a Member of The Association for Healthcare Resource and Materials Management and is Currently a Senior Sales Executive for a Healthcare/Medical Device Corporation.

This highly qualified engineering expert specializes in water treatment engineering, design, and operations. He is a certified water treatment and distribution operator. He belongs to a number of prestigious societies in the water treatment field and has authored more than 5 publications on the topic. This expert is currently a private water treatment industry consultant.

This highler qualified expert has two decades of experience in basic and applied reserach in the thermal sciences. He has published well over 100 scientific papers dealing with biological heat transfer, burn injuries, and medical devices, among others. He has consulted for many companies in the medical device field and has presented well over 100 technical presentations at conferences and meetings. He is a Full Professor at a major Minnesota University.

This qualified electric shock expert obtained his BS and MS in Bioengineering and Engineering Science from Stanford University and his PhD in Biomedical Engineering from Duke University. He is a Certified Professional Engineer and is a member of multiple engineering and bioengineering associations. The expert has published 75+ articles on electric shock and medical devices. He is an Emeritus Professor of Biomedical Engineering at a top university in the South and remains active as a consultant.

This expert is very well qualified the field of electrical engineering and power source design and qualification. He received his BS and ME in Biomedical Engineering from Worcester Polytechnic Institute. He is a member of the Board of Directors of the Power Sources Manufacturing Association and several branches of the Institute of Electrical and Electronic Engineers including IEEE Consultants Network and Chairs the San Francisco Bay Area IEEE Power Electronics Society. This expert specializes in analog/digital power and design as well as hardware failure analysis, manufacturing, and market analysis. He is currently a Principal at a power design consultancy that specializes in enterprise-level and consumer applications.

This engineering expert obtained his BS in Civil Engineering, with a specialization in Construction Management, and his MS in Structural Engineering from Stevens Institute of Technology. He is licensed as a Professional Engineer and a Structural Engineer in over 25 states and is certified by the Structural Engineering Certification Board. He is a member of ASCE, ACI, AISC and a Fellow of SEI. He serves as Chair of the ASCE SEI Business Practices Committee. He also serves on the Board of Trustees for Stevens Institute of Technology and the Board of Governors of the Structural Engineering Institute. He has 6 publications and is currently the Principal Engineer for a structural and forensic engineering firm.

This expert's professional career has spanned 50 years, while for the past 20 years he has specialized in guiding companies through the CE marking process for products prepared to enter the EU market and for companies in the US who want CE marking on their products for market flexibility and/or liability protection, many of which are medical devices and machinery. This expert conducts forensic legal analysis of companies' Quality Management Systems (ISO 9001), Environmental Management Systems (ISO 14001), and Quality System Regulations as stipulated by the FDA. He has hosted over 450 seminars and workshops and has published more than 300 articles and multiple books in the areas of Liability, EU Directives/CE Marking, Technical Standards, FDA Quality System Regulations, and ISO 90001 and 14001. He has developed and delivered on-site training programs on product liability exposure for medical device insurance companies, as well as for corporate counsel, defense counsel, and trial attorneys involved with medical devices and medical device manufacturers. As a Senior Consultant for both Excel Partnerships and SAI Global, he also developed and delivered on-site training programs on CE marking for the Medical Devices Directive and related Quality Management Systems. As Legal Expert/Expert Witness he has prepared legal materials for use in litigation involving Quality Systems and CE marked products as well as EU Administrative Reviews.