Biomechanical engineering consultant for medical device evaluation and testing

Consultant for Medical Device Design, Development and Testing (1411)

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.

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.

7 patents in the areas of:

Seven Professional Publications