Jay Kadakia Email & Phone Number

Silver Spring, MD

• Center for Devices and Radiological Health (CDRH)/ Office of Health Technology (OHT) 6 Orthopedic Devices/ Division of Health Technology (DHT) 6B Spinal Devices/ Team of Health Technology (THT) 6B2 Extracolumnar Spinal.
• Continually serve as an interdisciplinary engineer to independently lead reviews and evaluate scientific data submitted to the Agency by Industry to determine safety and efficacy of high level and complex orthopedic.
• Review work includes experience in the following premarket programs: 510(k)s (Premarket notification), Humanitarian Device Exemptions (HDE),Investigational Device Exemptions (IDE), Premarket Approval (PMA).
• Review work experience encompasses the following device types: total hip arthroplasty devices (constrained and semi-constrained configurations, including dual mobility systems); patient-matched cutting guides and.
• Serve as Additive Manufacturing (AM) and Magnetic Resonance (MR) expert for OHT 6
• Actively participate in ISO TC150 JWG1 and ASTM F42 for the development of standards associated with additive manufacturing in surgical implant applications.

Washington D.C. Metro Area

• Center for Devices and Radiological Health, Office of Surveillance and Biometrics
• Research current technical standards used by Issuing Agencies (IA) that distribute Unique Device Identifiers.
• Analyze qualification systems used as criteria for IA accreditation.

Indianapolis, Indiana Area

• http://www.iupui.edu/~bbml/index.shtmlLoading Interaction Study
• Spearheaded research project by developing scope of project and defining detailed testing procedures like identifying testing groups and quantitative methods to measure data of specific loading cycles and establishing.
• Improved mechanical testing of bone by analyzing the effect of high impact, fatigue, and combination of both in monotonic testing of cortical beams from canine femur.
• Wrote software platform to evaluate fatigue data in order to calculate important mechanical properties such as ultimate stress, ultimate force, yield stress, stiffness, modulus and displacement.
• Utilized statistical analyses by running 2-way ANOVA tests on data sets thereby measuring the interaction and main effects of impact and fatigue.Osteogenesis Imperfecta (OI) Mice Fixation Study
• Examined wild type (WT) and OI mice tail tendon using atomic force microscopy imaging in order to measure collagen fibril D-spacing.

Indianapolis, Indiana Area

• Fall 2014 - Biofluid and Biosolid MechanicsSpring 2015-16 - Transport Processes in Biomedical EngineeringFall 2015 - Biomechanics
• Mentored and tutored students to provide a deeper understanding of respective content, reinforce learning concepts and master assignments.
• Assisted professor in gathering class statistics through activities such as grading homework and exams as well as computing and recording results.
• Guided students in lab and lecture sessions through demonstrations of laboratory equipment, enforcement of laboratory rules and proctoring exams.

• Piloted a project that required the use of Aeroscout’s RFID tags and Exciters to track patients in a facility outside the main hospital.
• Utilized Cisco Systems to calibrate Exciters according to various room dimensions, operated an Aeroscout System Manager to position Exciters on a virtual map and utilized Aeroscout software to calibrate RFID tags to.
• Extracted, filtered and analyzed data from Aeroscout System Manager to trace routes of patients and their interactions with clinicians.

Master Of Science (M.S.), Biomedical/Medical Engineering, 3.31

Activities and Societies: Biomedical Engineering Graduate Student Association: President March 2015 - May 2016.

Bs, Biomedical/Medical Engineering, 3.1

Education record