OUR PEOPLE
Academic Credentials
- Ph.D., Biomedical Engineering, Rutgers University, 2016
- B.S., Biological Engineering, University of Florida, 2009
Licenses & Certifications
- Project Management Professional (PMP)
Professional Affiliations
- Orthopaedic Research Society
- ASTM International
Languages
- Tamil
Dr. Abraham's fields of expertise are focused on orthopaedics, orthobiologics, biomaterials, and translational research.
Dr. Abraham is an accredited Project Management Professional and has prior experience in managing large scale projects involving teams of people across multiple scientific and engineering disciplines. Dr. Abraham's project management experience includes leading multiple high performing, cross-functional, and interdisciplinary teams which impacted stakeholders within the pharmaceutical and medical device industries to deliver business, R&D, regulatory, and risk management strategies.
Dr. Abraham has supported medical device manufacturers in a variety of applications throughout the total product life cycle for Class I, II, and III medical devices. Her work includes, for example, providing design verification testing such as MRI safety labeling for medical devices, assessment of quality management systems and manufacturing lines, postmarket surveillance support, and reviewing and assembling regulatory submissions. She is knowledgeable with respect to a number of important industry standards and regulations impacting the medical device industry including ISO 13485, ISO 14971, 21 CFR 820, and 21 CFR 1271. She currently is an active member of the Orthopaedic Research Society and ASTM International's Tissue Engineered Medical Products Subcommittee. Dr. Abraham is proficient in running pre-clinical trials, animal surgical techniques, microCT analysis, histology, statistical analysis, failure analysis, and developing Institutional Animal Care and Use Committee (IACUC) and Institutional Review Board (IRB) protocols.
Prior to joining Ä¢¹½tv, Dr. Abraham earned her Ph.D. in Biomedical Engineering from a joint program at Rutgers University and the New Jersey Institute of Technology. During the course of her Ph.D. she worked with orthopaedic surgeons, business development teams, and engineers to develop new regenerative medicine technologies. Her research included the use of in vivo and in vitro models to assess the safety and efficacy of orthobiologic adjuncts, biomaterials, and pharmaceuticals.
Dr. Abraham has prior experience working in the private sector at Arthrex, Inc. with the Validation Engineering group. Here she gained skills for Class II and III medical device validation conforming to ISO 13485 standards. Dr. Abraham drafted and executed IQ/OQ/PQ protocols for equipment and processes adhering to cGMP and 21 CFR 820. Her primary focus here was to validate and incorporate new manufacturing processes into the current manufacturing system.
