- Mechanical and biomedical engineering.
- Accident reconstruction: Auto, motorcycle, bicycle, pedestrian, railroad, marine and aviation.
- Forensic engineering.
- Injury causation biomechanics.
- Product liability.
- Engineering analysis/research and development.
- Medical devices.
- Patent infringement.
- Regulatory affairs.
Undisclosed Company, President and CEO, 2008 - Present
- Engineering consulting firm specializing in: Mechanical and biomedical engineering, accident reconstruction, injury causation biomechanics, product liability, engineering analysis, research and development, medical devices, patent infringement and regulatory affairs.
Undisclosed Company, Senior Consultant, Medical Devices, 2008 - 2009
- Preparation and critical review of all types of medical device regulatory document filings to the FDA including pre-IDE, IDE, 510(k) and PMA submissions.
- Product development and research for: Drug/device and biologic/device combination products, medical devices, including engineering testing and requirements.
- Creation, implementation and review of client-specific regulatory strategies.
- Planning, writing, review of responses to agency questions.
- Development of client training classes to help clients better understand the regulatory process as related to medical device submissions.
Boster, Kobayashi, and Associates, Livermore, California, 2006 - 2008
- Specialist in the technical aspects of accident reconstruction and highway design.
- Application of laws of physics and principles of biomedical engineering in accident reconstruction, premises/product liability and injury causation.
Santa Clara University, Mechanical Engineering Department, Santa Clara, CA, 2008
- Developed and taught two new courses: Comparative Biomechanics I: Fluids; and Comparative Biomechanics II: Solids and Structures. Each focused on the application of engineering principles to the physical world.
Food and Drug Administration (FDA), Rockville, MD, 2002 - 2006
Center for Devices and Radiological Health, Mechanical/Biomedical Engineer - Reviewer
- Reviews predominantly involved pre-IDEs, (Investigational Device Evaluation-Exemptions) IDEs, and to a lesser extent 510k and PMA (Premarket Approval) submissions from the medical device industry.
- Lead medical device reviewer within the Interventional Cardiology Devices Branch in the Office of Device Evaluation (ODE) for cardiovascular medical devices.
- Engineering reviews of drug eluting stents and standards development activities for both the Interventional Cardiology Devices and the Peripheral Vascular Devices Branches.
- Primary FDA Liaison to ASTM F04.30.06 Interventional Cardiology Task Group and as Task Group Co-Chair.
ORISE Institute, Hydrodynamics and Acoustics Branch, Post Doctoral Fellow, 2001 - 2002
- Studied the amount of red blood cell damage (hemolysis) caused by medical devices in order to better predict hemolysis.
- Studied roller pumps, a device used in cardiopulmonary bypass surgery.
- Developed a reliable bench-top blood fragility tester.
- Laboratory studies continue and complimenting PIV flow visualization and Fluent FEM of several blood damage models.
Universities,1984 - 2006
- George Washington University, Washington, D.C., Mechanical and Aerospace Engineering Department. Developed and taught a new course, Biomechanics I, focusing on human biomechanics.
- Montgomery College, Germantown, MD, Mathematics, Science, Physics and Engineering Division. Taught Physical Science 101, a laboratory course for non-science majors, developed lectures, discussion and laboratory sessions.
- University of Connecticut, Mechanical Engineering Department, Storrs, CT, Fluid Mechanics Laboratory. Research on optimization of diffusers and turbine endwalls using the ice-formation method.
National Aeronautics and Space Administration, Moffett Field, CA, 1992 - 2001
Ames Research Center, Musculoskeletal Biomechanics Laboratory, Life Science Division
- Research in the Musculoskeletal Biomechanics Laboratory involving development of a Ground Reaction Force (GRF) sensor, direction of associated human research studies, and investigation of basic aspects of musculoskeletal remodeling.
- General: Heat transfer analysis and development of a finite element model using COSMOS/M for a Shuttle payload.
- Intercranial Pressure Research: Evaluation of response wave form (amplitude vs. time) in intercranial pressure.
Assistant Division Chief
- Represented the Life Science Division in meetings related to personnel, budget, projects, promotion and outreach.
Project Engineer, Human Powered Centrifuge Project
- Led the Human Powered Centrifuge Project.
Facility Engineer, Space Technology and Aeronautical Test and Simulation Divisions
- Worked in three different test facilities: Arc-Jet Facilities Complex, 3.5-Foot Hypersonic Wind Tunnel, 14-Foot Transonic Wind Tunnel.
- Investigated, inspected and diagnosed facility shutdown problems and accidents.
- Determined tunnel critical electrical devices and analyzed facility operational logic sequence.
- Designed an insert/retract mechanism for an oxygen sensor.
- Turning vane set inspection, evaluation, and repair, including scheduling and manpower.
- Performed structural and heat transfer calculations.
- Designed an insert/retract mechanism for an oxygen sensor.
- Selected various upgrades to facility equipment including pumps, thermocouples and valves.
Honors & Publications
Academic and Professional Affiliations
- Forensic Expert Witness Association
- Regulatory Affairs Professionals (RAPS)
- American Academy of Forensic Sciences (AAFS)
- National Academy of Forensic Engineers (NAFE)
- Society of Automotive Engineers (SAE)
- American Society for Testing and Materials(ASTM)Member and Primary FDA Liaison to ASTM F04.30.06 Interventional Cardiology Task Group and Task Group Co-Chair
- American Society of Biomechanics (ASB)
- Biomedical Engineering Society (BMES)
- American Society of Mechanical Engineers (ASME)
- Numerous patents, papers and presentations.
- Ph.D. Biomedical Engineering, University of Virginia
- M.S. Mechanical Engineering, Stanford University, CA
- B.S. Mechanical Engineering, University of Connecticut, CT