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Consultant for Medical Device Design, Development and Testing

Technical Consultant #1411


Expertise

  • Medical device evaluation and testing.
  • Skilled in mechanical laboratory testing and procedures for hard and soft tissue, joints and other devices such as artificial limb prosthetics and external fixation devices.
  • Conduct medical device laboratory testing for product development, third party device evaluations, and testing for regulatory submissions.
  • Testing of spinal implants and other orthopedic devices for FDA submission and other required pre-development testing for new devices.
  • Biomechanical evaluation and fatigue analysis of silicone breast implants.
  • Experienced applying mechanical engineering tools to biomechanical applications, including computer aided design, (CAD) and finite element modeling, (FEM) techniques.
  • Over twenty years of experience of using FEA and CAD programs as well as manual drafting practices for the design, development, analysis and testing of medical devices.
  • Presented and published papers on orthopedic problems and collaborated in development of patentable orthopedic devices.

Experience

Operates Medical Device Testing Laboratory, 2005 - Present

  • Provide medical device evaluation testing including 510(k) and Premarket Approval Applications (PMA).
  • Testing and design analysis for medical devices.
  • Manage daily operations of company with averaging greater than 30 projects annually serving an international client base.

Harrington Arthritis Research Center, Phoenix, Arizona, Various Positions, 1984 - 2002

  • As Director of Mechanical Testing Department, transformed under performing contract testing lab to a profitable and growing facility.

As CAD Engineer Specialist

  • Research advisor for Orthopedic Medical Residents in their biomechanical research projects.
  • Specialist in Finite Element Modeling using ANSYS.
  • Specialist in Computer Aided Design (CAD) using Prime Medusa, Pro/Engineer, and SolidWork's.
  • Collaborated with orthopedic companies including Biomed, ETEX Corp., Howmedica, Osteonics, Ortho Development, Zimmer, and others on projects in testing and developing of devices.
  • Co Inventor of the OrthoFrame external fixator and Harrington's Composite Hip Implant.

Miller Institute, Phoenix, Arizona, CAD Instructor, 1984

  • Instructor in the Design/CAD department for second and third term students.
  • Instructed students on ANSI and military standards for the applications of printed circuit board design and manufacturing.

Honors & Publications


7 patents in the areas of:

  • Apparatus for Delivering Cement
  • Unilateral External Fixation
  • Pin Clamp
  • External Fixation Device
  • Femoral Joint Prosthetic Device
  • Beam Construction and Method

Seven Professional Publications


Education

  • CAD Design, Miller Institute, Phoenix, AZ
  • B.S., Mechanical Engineering, Milwaukee School of Engineering
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