Sangeeta Abraham

Dr. Abraham is a biomedical engineer, a licensed Project Management Professional (PMP) and a Certified Quality Engineer (CQE) with expertise in quality and risk management within the medical device, pharmaceutical, and human cells, tissues, and tissue-based products (HCT/Ps) industries. Since joining Exponent Dr. Abraham has consulted for companies on numerous projects related to product development, manufacturing, quality management, risk management, regulatory affairs, postmarket activities, and failure analysis. She has served as a subject matter expert for a variety of products spanning Class I (e.g., adult portable bed rails), Class II (e.g., endotracheal tubes), and Class III (e.g., neurostimulators) medical devices as well as HCT/Ps (e.g., bone grafts).

Dr. Abraham has been a member of professional and standards organizations throughout her career, including the Orthopaedic Research Society (ORS), ASTM International (formerly American Society for Testing and Materials), Standards Coordinating Body (SCB), the Project Management Institute (PMI), the American Society for Quality (ASQ), and on professional committees within the Food and Drug Law Institute (FDLI). While serving as a member with ASTM and SCB she has participated in drafting, reviewing, and implementing various technical standards, including those for tissue-engineered medical products (TEMPs), implantable fibrous scaffolds, and MRI safety and compatibility of medical devices. In addition to the standards she has drafted or reviewed, Dr. Abraham is knowledgeable with respect to a number of other important industry standards and regulations impacting the medical device industry including ISO 13485, ISO 14971, 21 CFR 820, and 21 CFR 1271. 

Currently, Dr. Abraham holds a position on West Chester University's Biomedical Engineering Industrial and Professional Advisory Board (WCU IPAB) and has been a board member since 2019. During this time WCU IPAB has helped establish a Biomedical Engineering undergraduate degree program by providing guidance on the academic curriculum. In addition to establishing the new Biomedical Engineering program, WCU IPAB also played an integral role in the program's ABET accreditation.

Prior to joining Exponent, Dr. Abraham worked for a medical device manufacturer within the Validation Engineering department. Here, she was responsible for developing and executing various process and equipment validations for implants and surgical instruments and served as the lead validation engineer for activities related to the integration of a new multifunctional piece of manufacturing equipment into the existing production line.

Dr. Abraham has a Doctor of Philosophy (Ph.D.) in Biomedical Engineering from a joint program between the New Jersey Institute of Technology and Rutgers University. Her research was focused on orthopaedics, orthobiologics, biomaterials, and translational research. During the course of her Ph.D. she collaborated with orthopaedic surgeons, industry teams, and engineers to develop and study new regenerative medicine technologies. The research included the use of in vivo and in vitro models to assess the safety and efficacy of orthobiologic adjuncts, biomaterials, and pharmaceuticals in bone regeneration.