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Medical Device Process Validation Resume...
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Title Medical Device Process Validation
Target Location US-NJ-Hillsborough
Phone Available with paid plan
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Candidate's Name
Street Address  Fawn DriveLebanon, NJ Street Address
PHONE NUMBER AVAILABLESUMMARY: Process Engineering professional with experience in fast paced medical device manufacturing environment. Experienced in LEAN manufacturin Extensive experience in process validation and equipment qualification for medical device manufacture. Validated manufacturing processes per ISO 13485. Education: Rutgers the State University of NJ, New Brunswick, NJ 1988-1994 MS Ceramic Science Pennsylvania State University, State College, PA 1980-1984 BS Ceramic Science and EngineeringCertifications: Process Validation Principles and Protocols  Oriel STAT A MATRIX Internal Auditor Training for ISO 13485  Oriel STAT A MATRIX Minitab Essentials, Factorial Designs and Statistical Quality Analysis  Minitab LLC Autodesk Inventor Introduction to Solid Modeling  IMAGINiT Technical Training Services Excel Advanced  Corporate Training GroupSkills: Minitab statistical software MS-office suite (Excel, Word, Outlook, Powerpoint) SAP LIMS (LabsQ) QIM (software for quality issues)Core Qualifications: Process Validation and Equipment Qualification Materials characterization Adhesive assembly and automated equipment for adhesive assembly and packaging Process trouble shooting for LEAN manufacturing and OEE improvement Vacuum induction and air melt alloy processing Ceramic technology  powder processing, slip casting, sintering and controlled atmospheres. Refractory selection, structure design and application Excellent Project management skillsExperience:Ivoclar Vivadent Manufacturing Somerset NJProcess Engineer IIIJuly 2013 - Present Adhesive assembly of dental ceramic CAD/CAM materials. Responsible for automated and manual adhesive assembly processes. Familiarity with UV curing adhesives, epoxies, and other materials used in an ISO13485 medical device manufacturing environment. IQ/OQ of automated adhesive assembly production equipment. Qualification of industrial label printers for electronic planning and production control (ePPC) workplace. Qualification of US vendor for precision machined component of ceramic CAD/CAM block value streams (6M pieces/year).ALCOA Howmet Dover Alloy Dover NJProcess EngineerAugust 2009  July 2013 Responsible for materials optimization of melt crucibles, tundishes, ingot molds, and other refractories used in production of nickel and cobalt based super alloys. Familiar with vacuum induction melting, AOD refining and continuous casting. Obtained AS9100 internal audit certification. Supervised refractory team during monthly re-lining of induction melt crucibles. Inspection of refractory lining to extend service. Interpretation of metallurgical analyses (optical emission, mass spec, Leco carbon and sulfur). Reduction, recovery and characterization of scrap for remelt. Testing of new refractory materials for melter bricking, tundish assembly, hot top and insulation. Inspection and repair of induction coils.Morgan AM&T, East Stroudsburg, PA and Kingston ON Canada Project Engineer.March 2008 - December 2008 Manufactured ceramic products for molten metal foundry applications and ceramic armor. Slip casting of technical ceramics. Mold design. Technical ceramics sintering.Tiger Optics, Warrington PATechnical Service EngineerOctober 2007 to February 2008 Technical service for Tiger Optics PPB gas analyzers. Technical service for MEECO flammable gas analyzers. BOC Gases, Murray Hill NJStaff ScientistFebruary 1988 to March 2007 Pilot processing and characterization of proprietary adsorbent and catalyst materials. Co-inventor US Pat.#7070752 and #6358302. Operation of controlled atmosphere furnaces, screen printers, and circuit assembly equipment. Planned and executed experiments and customer demonstrations. Designed and fabricated chemical synthesis system for aluminosilicate zeolite molecular sieve materials. Used industrial soldering equipment to test controlled atmospheres for IR reflow furnaces. Porosity measurement for proprietary non-cryogenic air separation materials (N2 BET).

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