I have more than 40 years experience in Engineering and Medical Devices. My areas of expertise consists of hydroculators, moist heat pads, thermal cooling pads and cooling apparatus; laser and thermal hair removal devices, dermabrasion equipment; luggage and costume jewelry; patient beds, transport gurneys; failure of Pilates exercise devices; surgical staples; surgical fluid warmers; pedicle screw failure; absorbable shoulder tacs; suture failure; chiropractic devices; dental burr and drill failures; defibrillator mechanical design issues; surgical laser power cord design reliability, and much more. My additional experience includes engineering and management focused on research and development, design, and manufacturing in the medical device, packaging, toy, consumer product, and aerospace industries. My responsibilities have ranged from original product conception through high volume manufacturing, including plastic extrusion, injection molding, assembly, decorating, labeling, and packaging. I have experience with FDA requirements and Good Manufacturing Procedures (GMP’s); producing prototype models; performing computer aided plastic part design (SolidWorks) and failure; and hazard analysis including Failure Mode Effects Analysis (FMEA). I have over 10 years expert witness experience.