with FDA regulated environment ISO-13485 and GMP regulation/Standard Operation Procedure for Medical Industry. * Experience with designing automation control systems for a blow-molding machine tubing stretcher burst tester injection molding and balloon-folding machine. * Experience with Technical Support to customer and Test Equipment. * Use of electrical test equipment inspection equipment to troubleshoot process machinery. * Experience designing medical devices with metals plastics and nitinol alloys. Experienced with wire harness design, and creating schematic diagrams for Electro-Mechanical medical devices and their associated automated production machinery. * Experience with process equipment development and process equipment validations (IQ/OQ/PQ) for medical device, blow molding, injection molding and balloon forming machine within (FDA) regulated environment (i.e. Medical Device, Bio-Technology, and Pharmaceutical Industry). * Well trained in Six Sigma, Lean manufacturing, Just-In-Time (JIT) and improvement of existing products or process use the Six Sigma methodology (DMAIC) and (FMEA).
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