Medical Device Expert Witness

This expert has over 25 years of experience with medical device and manufacturing quality assurance and engineering. He earned his MSEP in engineering physics and applied physics from Uppsala University and his MSME in mechanical engineering from the University of Houston. He has formerly served as a materials engineering consultant at Law Engineering, a manager of quality engineering at Boston Scientific and Mentor Worldwide LLC, and the director of quality at ...

This highly qualified expert has over 40 years of experience in medical device regulations. He received his BS in chemical engineering from Lowell Technological Institute and earned his MS in chemical engineering from the University of Iowa. He currently has 5 patents. Over the years, his work has included antimicrobial development and application, hydrophilic coating development and implementation, and over-the-counter and personal care product development. His former ...

This expert has over 15 years of experience in progressive engineering, operations, and project management leadership in the highly regulated automotive, medical device & food manufacturing industries. He was a senior continuous improvement engineer for American Medical Systems, where he managed CAP and various engineering projects to improve system compliance for FDA class III medical devices. During this period, he had direct experience with implantable penile device ...

This expert earned his BS in bioengineering from the University of California, San Diego. He has over 20 years of experience in the medical device design industry, and holds over 40 issued patents. Previously, this expert served as a group manager and senior R&D engineer with Pfizer-Shiley & Mallinckrodt Medical, as vice president of operations at Pulmonx Incorporated, and as vice president at Breathe Technologies. Currently, this expert serves as the senior vice ...

This highly-qualified expert has extensive experience in automated external defibrillator (AED) program design and compliance. He earned his BS in public affairs from the University of Oregon and his JD from the Lewis & Clark Northwestern School of Law. He is a member of the Oregon State Bar and an advisory board member of the Sudden Cardiac Arrest Foundation and the National Center for Early Defibrillation. He has been the founder of several firms, including Lazar ...

This expert has over 30 years of experience in the medical device industry, with broad expertise in cardiovascular and endovascular fields with a focus on percutaneous catheters, heart assist devices, brain and aortic aneurysm treatment, and vascular closure products. He earned his MS in mechanical engineering at Moscow State Technical University and worked as the lead engineer at the Scientific Institute for Transplantology and Artificial Organs before moving to the ...

This expert in material sciences and electrochemistry received his BA in bio-engineering from the University of Pittsburgh before studying medical device fabrication science and then obtaining his PhD in physics at the University of Melbourne. He has experience with medical devices such as neural stimulators, neural recorders, and chemical sensors. This expert has two approved patents and two pending patents relating to materials used for medical devices and has ...

This Washington-based expert has over 20 years of experience in chemistry and medical device research, specializing in polymer synthesis, polymer characterization, analytical chemistry, medical device design and intellectual property management. He received his BES in chemistry and photographic sciences from St. Cloud State University before earning his PhD in polymer chemistry from the University of Southern California. He is active in his field as a member of the ...

This highly-qualified expert has nearly 30 years of experience as an epidemiologist and nurse-midwife, with demonstrated experience in medical device safety including gynecologic surgical mesh, breast implants, hip replacement, cardiovascular and dermatologic devices, post-market surveillance, and pharmacoepidemiology. She received her BS in biology from the University of Illinois and a diploma in nursing from Evanston Hospital School of Nursing before earning her BS in ...

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 ...

This highly qualified expert has over 15 years of experience specializing in the electro-mechanical systems in medical devices. Specifically, this expert specializes in oxygen concentrators, oxygen conserving devices, breathe detection, power circuit design, instrumentation, and sensing. He earned his BS in electrical engineering from Northwestern and his MBA from Kellogg Graduate School of Management and has his six sigma black belt certification. He has held several ...

This expert has over 30 years of experience in medical device development, specifically cardiovascular devices. He earned his BS in chemical engineering from Arizona State University and is a member of the International Society for Endovascular Specialists. This expert has a high level of clinical expertise for surgical, vascular and endovascular devices and procedures and is well versed in implantable device failure investigation and evaluation. He previously served as ...