My experience includes R & D, production and management activities from original product conception to high volume manufacturing. I have been directly involved with plastic extrusion, injection molding and decorating in the aerospace, medical device, packaging, toy and consumer product industries. I am skilled in the development of prototype models, performing computer aided plastic part design and failure & hazard analysis. I hold 30 U.S. Patents, 27 of which are for medical devices.
I have served as an expert witness for close to 20 years working with defense and plaintiff’s attorneys and insurance companies involving a broad range of legal issues. My areas of expertise include design, engineering, patent, trademark, medical devices, packaging, labeling and product liability matters. I have extensive engineering experience and a broad perspective of product design and product liability issues including the importance of product testing, manufacturing, labeling design, packaging and fail-safe design implementation.
I have served on medical standards committees, worked with industry and government regulatory agencies and I have intimate knowledge and experience with FDA requirements including good manufacturing procedures. (GMP’s)
I have been the vice president of engineering for several start-up companies including one focused on female incontinence. I was also a co-founder of a medical device company producing male incontinence products.
My military service was in the US Army where I served as an engineering company commander