Biomedical and Biomechanical Consulting Engineer: Forensics Investigation, Accident Reconstruction, Injury Causation and Products Liability Expert Witness

Technical Consultant #1564

Mechanical and biomedical engineering.
Accident reconstruction: Auto, motorcycle, bicycle, pedestrian, railroad, marine and aviation.
Forensic engineering.
3D laser scanning.
Injury causation biomechanics & personal injury.
Product and premises liability.
Engineering analysis/R&D/FEA.
Medical devices and regulatory affairs.
Patent infringement.

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

Mechanical/Biomedical Engineer

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

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.

Technical Projects

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.

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)

Publications