SUMMARY OF QUALIFICATIONS * Principal engineer, R&D and general management executive and scientific professional with B.S. M.S., Ph.D. and postdoctorate in science and engineering disciplines. * Successfully developed several prototypes and launched multiple FDA/CE regulated platforms, devices and Class I-II-III products and plastic consumables for medical, diagnostics, biotech and pharmaceutical applications from concept to product launch, manufacturing, automation and cost reduction. * 12+ years post-graduate and industry result-oriented experience in GMP, cGMP, GLP, EHS, CE, ISO and FDA regulated positions, 8+ years of which was also served in executive and management roles. * Hands-on experience working with various engineering, R&D, quality and management processes, tooling, software and methods including IQ/OQ/PQ/DQ/PV, FMEA, LEAN, QSR, QMS, QC/QA, CAR/PAR/NCR/CAPA, Design Control, PDP, SOP, WI, MP/IP/BOM, JMP, ANOVA, Modern DOE & SPC, CAD, SolidWorks, Rapid Prototyping, SLA/FDM, 3D/CFD Modeling, and LabVIEW. * Creative leader awarded with multi-million dollar government and private grants and contracts with proven record of 100+ patents, publications and technical and business presentations.
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