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

Technical Consultant #1564


Expertise

  • 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.

Experience

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

  • 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.

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.

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)

Publications

  • Numerous patents, papers and presentations.

Education

  • Ph.D. Biomedical Engineering, University of Virginia
  • M.S. Mechanical Engineering, Stanford University, CA
  • B.S. Mechanical Engineering, University of Connecticut, CT
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