Description
Summary: Nineteen years of diverse experience with medical device organizations in R&D, Manufacturing and Process Development with skills in: Mechanical Heart Valve, Tissue Heart Valve, Cryoablation, Artery Bypass Connector, Thoracic aneurysm graft and R&D anti-coagulation coating technology. Five years experience as a pyrolytic carbon machinist in a cellular manufacturing team. Partnered with engineering on stented tissue valve. R&D in-vitro bench top studies and Pre-clinical in-vivo studies. Participant in FIH project. Developed fixtures and test methods for new catheter. DHF remediation project for acquired cryoablation device. Characterization for new sheath material on cryoablation device. * Lean Manufacturing Patent No.: US 8,653,632 B2 FDA Regulated Experience GMP / JIT Cellular Manufacturing Statistical Process Control, SPC Continuous Quality Improvement MS Word, Excel, Visio and Minitab Competent Trouble Shooting & Process Improvement Cycle Time Reduction ISO 13485: QMS and FDA QRS Process Validation (TLI-214) ISO 9001 FDA 21 CFR, Part 820 QSR (TLI-208) QSR Quality Systems Regulation Training (All Modules) Olympus Manufacturing Technician May 2015-Present Experienced with automated measuring devices: CMM, SmartScope, Oscilloscope, Multi-meter, Micro-Vu, Optical Comparator, X-ray, Tool and Camera Scopes. * MTS and Instron compression/tensile testing. Master Cam 9.1 programming. * Laser welding and measuring systems, adhesive chemistry, forming and soldering. * Production Laser operator, experienced with various classes of Nd Yag Laser systems Experienced with Mori Seiki MV40 4-axis mill, machining coated orifice, first article inspections.
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