Medical Devices Expert Witnesses in Texas

This highly experienced biomedical engineer has directed comprehensive hospital-based biomedical engineering department at the largest medical center in the country, taught at both medical and technical post-secondary institutions, including the Baylor College of Medicine, West Virginia University, and a prominent Mexican university. He earned his undergraduate and graduate degrees in electrical engineering from West Virginia University. He is a licensed Professional Engineer and certified as a Clinical Engineer. He is member of technical standards writing bodies, and is widely published in his field and his expertise is frequently sought by hospitals, manufacturers, and litigators. He received numerous professional awards including the FDA Commissioner, Special Citation for protecting the public safety.

This expert joined the Departments of Bioengineering and Mechanical Engineering at a major TX University in June 2013 as an Assistant Professor. Prior to joining that university, he was a Research Scientist at the Rehabilitation Institute of Chicago and a Postdoctoral Fellow at Northwestern University. This expert investigates the control mechanisms of human locomotion for the development of high-performance wearable control systems (e.g., robotic prostheses and orthoses) to enable mobility in persons with disabilities. He is a recipient of the NIH Director's New Innovator Award and the Career Award at the Scientific Interface from the Burroughs Wellcome Fund. His work has been recognized with the Best Student Paper Award of the American Control Conference and the IEEE Conference on Decision & Control, the Best Technical Paper Award of the 2011 CLAWAR Conference, and the O. Hugo Schuck Award from multiple control conferences and councils, respectively. He is a Senior Member of the IEEE Control Systems Society and the IEEE Robotics & Automation Society.

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 expert has successfully aided many national and international medical device companies with on-site help during FDA audits, FDA-483 responses, Warning Letter Responses, Consent Decree Corrections, ISO audits and readiness, developing and implementing compliant quality systems. She is a former FDA Regional Medical Device Expert and currently provides personalized, FDA regulatory and quality solutions and training to both small and large companies, and entrepreneurs. This expert has been invited to speak nationally, and has authored 6 publications in FDA regulatory and quality matters.

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 roles including VP of engineering at Joslyn Hi-Voltage, director of electrical engineering at Baxter Healthcare and director of device risk management at Hospira. This expert also served as the director of global respiratory engineering in the home medical equipment division of Invacare. Currently, this expert owns a consultancy focused on the medical device product development in TX.