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STEVEN ARTHUR STEIN
31525 Marchester Drive
Wesley Chapel, Florida, 33543
703.283.7028 Linkedin Profile: Steven Stein sas10@verizon.net
CAREER SUMMARY
Highly dedicated and results-oriented manufacturing professional. Extensive experience in development,
production, and operation of radio isotope detection / analytical instruments, and medical devices for the
pharmaceutical Industry. Highly successful background in industrial sales.
Proven expertise in:
• Operations / Field Service Management • IT Networking & Infrastructure Development
• ISO 9001 / 13485 Quality System Implementation • MRP / ERP System Planning & Setup
• Medical Product Development & Testing Design • CE, TUV, U/L & CSA Product Certification
• cGMP / cGDP / cGLP Operations & Setup • Radio Isotope Detection Equipment Design
• Lean, Six Sigma, 5S training
PROFESSIONAL EXPERIENCE
UPS STORE
Store Lead Associate & Notary Public
Operation of Franchise UPS STORE, Tampa, FL
October 2014 – April 2016
Ran Daily Logistics Operation of 2 Different UPS Facility with full responsibility for sales, data collection,
receipt operation, data management, and shipping and Packing of outgoing product and sales.
Manufacturing Engineer, Lablogic Systems Inc., Brandon, FL
September 2014-October 2014 (2 months)
Manufacturing Engineer, GE Healthcare
February 2014 – March 2014 (2 months) Laurel, MD
Working for Noramtec Consultants Americas Inc at GE Healthcare in Laurel, MD In Maternal-Infant care
equipment manufacturing plant. Worked on RoHS compliance and FDA Audit findings for legacy equipment
documentation. Contract ended early.
Logistics Engineer, Northern Virginia
November 2013 – January 2014 (3 months) Walmart-Tysons Corner
Logistics Engineer working part-time at Walmart to maintain stock as it arrives and make sure floor stock is
correct
Retired
IBA MOLECULAR N.A., Sterling, VA 2006 –1/2013
Director of Manufacturing, Laboratory Equipment
Coordinated design, setup and operation of laboratory instrument manufacturing facility and supported
implementation of ISO-13485 / 9001 Quality Management System (QMS). Managed all product and process
certification activities (e.g., European Certification [CE], Food and Drug Administration [FDA], Underwriter’s
Laboratory [U/L], Federal Communications Commission [FCC], Canadian Safety Association [CSA], German
product testing and certification [TUV], Current Good Manufacturing Practices [cGMP]). Purchased all raw
materials for Synthera Product Line, maintaining >$1.5M in inventory for Production Group and Technical
Service Group. Developed and maintained Manufacturing Resource Planning (MRP) and Enterprise
Resource Planning (ERP). Hired and trained highly productive and efficient manufacturing team.
• Launched Synthera Version 1 product line, which netted sales of >$2M in 2007.
• Provided extensive product / packaging design support for new pharmaceutical equipment to ensure
safe shipping to international destinations.
• Developed, implemented and managed product development and manufacturing operations, producing
>200 systems in 5 years.
• Instituted blanket purchase orders (PO), reducing manufacturing cost for product line by >60%.
• Recognized for establishing highly effective manufacturing operation and for successfully
transitioning prototype equipment into manufactured products.
• Implemented highly successful ISO13485:2003 QMS System in June, 2008, with 0 non-conformances
identified during 2009 and 2010 re-certification audits.
BIOSCAN, INC., Washington, DC 1992 –2006
Service Manager
Coordinated design, setup and operation of internal IT Infrastructure and shop layout for Manufacturing.
Provided engineering and service support for board-level prototyping, repairs and debugging. Provided
integration and testing support for 3rd
-party software (e.g., Lablogic Laura3) and Original Equipment
Manufacturer (OEM) software (e.g., Bio-Chrome Software) for all Bioscan-made Instruments sold.
• Served as purchasing agent and designator of components for both Manufacturing and Research and
Development (R&D), and lowered material cost by 60% with blanket purchase orders.
• Developed and conducted training courses for external distributors and internal personnel to develop key
skills and competencies using Bioscan equipment.
• Collaborated with lead team which helped start Nuclear Interface-USA and provided support for
installation of Nuclear Interface (NI) Fluorodeoxyglucose (FDG) and Carbon 11 (C11) instruments for use
in modern medical nuclear imaging, P.E.T. (Positron Emission Tomography) scans.
• Supported and trained engineers developing and assembling product lines to assist in gaining essential
understanding of products to perform troubleshooting and quality control.
• Provided design / prototyping support for AR-2000 TLC scanner, Mini-scan, Flow Count and Hot Cell
Radioactivity Monitoring Systems to allow production of new devices.
• Performed all CE and regulatory testing of products with area test labs so devices could be sold
overseas.
• Conducted extensive service activities on all brands of analytical instruments to fulfill service contracts
on devices.
• Provided exceptional customer support by coordinating direct field service support for products and
applications.
• Worked with outside vendors to setup turnkey OEM production facilities for some items with 50-70% cost
reduction and increased profit margins.
C.F.E. EQUIPMENT CORPORATION, Norfolk, VA
Assistant General Manager and Sales Manager
Served as only Sales Representative for entire region. Provided extensive sales expertise in Material
Handling Systems from Nissan, Crown, Simon, Bobcat, and Taylor lift trucks.
• Designed and installed $50M automated storage / retrieval systems at Norfolk Naval Air Station where
storage was increased by 400% using 75% less people.
• Generated >$100M yearly in sales to commercial customers by offering best service and products for
needed applications.
• Initiated and successfully negotiated $3B contract for use of “SANDROID” robotic system by cleaning
USS John F. Kennedy in 49 days during President Reagan’s Navy build-up.
• Negotiated and won >$300M in contracts with other military agencies through skilled proposal
submissions meeting Department of Defense contracting requirements
AMERICAN MATERIALS HANDLING, INC., Reading, PA
Assistant Manager
Directly assisted in start-up of first US “Datsun” (Nissan) forklift dealership in America. Performed multiple
duties (e.g. Service Technician, Parts Manager, Sales and Sales Manager). Sold >700 forklifts and
designed >50 major materials handling systems for industrial and commercial firms in PA, NJ, MD, and DE.
EDUCATION
• 225 credits towards BSEE and ME (Dual Degree), Lehigh University, Lehigh, PA
• AS with High Honors, Electronics Engineering Technology, ITT Technical Institute, Norfolk, VA
• LIFE: 50 years’ experience in sales, service, and customer support roles
STEVEN ARTHUR STEIN PAGE THREE
COMPUTER SKILLS
• Microsoft Office / VISIO / Sharepoint
• Adobe Acrobat / Photoshop
• SOLIDWORKS 2007 / 2008 / 2009
• Lablogic Laura 3 / Laura 4 LIMS
• Windows (2000, NT, XP, VISTA,Win7 Pro) • SPC Software (QI Analyst, SPSS)
• MRP / ERP Software (SAP, JD Edwards,
Peoplesoft, DBA Manufacturing, MAX)
• Agile, Oracle ERP
PROFESSIONAL DEVELOPMENT
• Radiation Safety Officer (RSO) Training, Radiation Safety, Inc. Bethesda, MD
• Microsoft MCSE Training (Cert. Awarded), Microsoft
• Service Training for HPLC Products, Lab Alliance
• Service Training for MeI Stations, GE Medical Systems Uppsla, Sweden
• Win 3.1, 95, 98 NT / W2K, XP Server 2000 – 2003, Computer Learning Center, NVCC
• Solidworks 2008 Training, Tri-Mech, Columbia, MD
• ISO 13485:2003 Training, IBA Molecular N.A.
• Professional Certified in Materials Handling, IMMS (now MHMS)
• Oracle and Agile training at GE Healthcare, Laurel, MD

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CV-FORMAT Stein Steven

  • 1. STEVEN ARTHUR STEIN 31525 Marchester Drive Wesley Chapel, Florida, 33543 703.283.7028 Linkedin Profile: Steven Stein sas10@verizon.net CAREER SUMMARY Highly dedicated and results-oriented manufacturing professional. Extensive experience in development, production, and operation of radio isotope detection / analytical instruments, and medical devices for the pharmaceutical Industry. Highly successful background in industrial sales. Proven expertise in: • Operations / Field Service Management • IT Networking & Infrastructure Development • ISO 9001 / 13485 Quality System Implementation • MRP / ERP System Planning & Setup • Medical Product Development & Testing Design • CE, TUV, U/L & CSA Product Certification • cGMP / cGDP / cGLP Operations & Setup • Radio Isotope Detection Equipment Design • Lean, Six Sigma, 5S training PROFESSIONAL EXPERIENCE UPS STORE Store Lead Associate & Notary Public Operation of Franchise UPS STORE, Tampa, FL October 2014 – April 2016 Ran Daily Logistics Operation of 2 Different UPS Facility with full responsibility for sales, data collection, receipt operation, data management, and shipping and Packing of outgoing product and sales. Manufacturing Engineer, Lablogic Systems Inc., Brandon, FL September 2014-October 2014 (2 months) Manufacturing Engineer, GE Healthcare February 2014 – March 2014 (2 months) Laurel, MD Working for Noramtec Consultants Americas Inc at GE Healthcare in Laurel, MD In Maternal-Infant care equipment manufacturing plant. Worked on RoHS compliance and FDA Audit findings for legacy equipment documentation. Contract ended early. Logistics Engineer, Northern Virginia November 2013 – January 2014 (3 months) Walmart-Tysons Corner Logistics Engineer working part-time at Walmart to maintain stock as it arrives and make sure floor stock is correct Retired
  • 2. IBA MOLECULAR N.A., Sterling, VA 2006 –1/2013 Director of Manufacturing, Laboratory Equipment Coordinated design, setup and operation of laboratory instrument manufacturing facility and supported implementation of ISO-13485 / 9001 Quality Management System (QMS). Managed all product and process certification activities (e.g., European Certification [CE], Food and Drug Administration [FDA], Underwriter’s Laboratory [U/L], Federal Communications Commission [FCC], Canadian Safety Association [CSA], German product testing and certification [TUV], Current Good Manufacturing Practices [cGMP]). Purchased all raw materials for Synthera Product Line, maintaining >$1.5M in inventory for Production Group and Technical Service Group. Developed and maintained Manufacturing Resource Planning (MRP) and Enterprise Resource Planning (ERP). Hired and trained highly productive and efficient manufacturing team. • Launched Synthera Version 1 product line, which netted sales of >$2M in 2007. • Provided extensive product / packaging design support for new pharmaceutical equipment to ensure safe shipping to international destinations. • Developed, implemented and managed product development and manufacturing operations, producing >200 systems in 5 years. • Instituted blanket purchase orders (PO), reducing manufacturing cost for product line by >60%. • Recognized for establishing highly effective manufacturing operation and for successfully transitioning prototype equipment into manufactured products. • Implemented highly successful ISO13485:2003 QMS System in June, 2008, with 0 non-conformances identified during 2009 and 2010 re-certification audits. BIOSCAN, INC., Washington, DC 1992 –2006 Service Manager Coordinated design, setup and operation of internal IT Infrastructure and shop layout for Manufacturing. Provided engineering and service support for board-level prototyping, repairs and debugging. Provided integration and testing support for 3rd -party software (e.g., Lablogic Laura3) and Original Equipment Manufacturer (OEM) software (e.g., Bio-Chrome Software) for all Bioscan-made Instruments sold. • Served as purchasing agent and designator of components for both Manufacturing and Research and Development (R&D), and lowered material cost by 60% with blanket purchase orders. • Developed and conducted training courses for external distributors and internal personnel to develop key skills and competencies using Bioscan equipment. • Collaborated with lead team which helped start Nuclear Interface-USA and provided support for installation of Nuclear Interface (NI) Fluorodeoxyglucose (FDG) and Carbon 11 (C11) instruments for use in modern medical nuclear imaging, P.E.T. (Positron Emission Tomography) scans. • Supported and trained engineers developing and assembling product lines to assist in gaining essential understanding of products to perform troubleshooting and quality control. • Provided design / prototyping support for AR-2000 TLC scanner, Mini-scan, Flow Count and Hot Cell Radioactivity Monitoring Systems to allow production of new devices. • Performed all CE and regulatory testing of products with area test labs so devices could be sold overseas. • Conducted extensive service activities on all brands of analytical instruments to fulfill service contracts on devices. • Provided exceptional customer support by coordinating direct field service support for products and applications. • Worked with outside vendors to setup turnkey OEM production facilities for some items with 50-70% cost reduction and increased profit margins.
  • 3. C.F.E. EQUIPMENT CORPORATION, Norfolk, VA Assistant General Manager and Sales Manager Served as only Sales Representative for entire region. Provided extensive sales expertise in Material Handling Systems from Nissan, Crown, Simon, Bobcat, and Taylor lift trucks. • Designed and installed $50M automated storage / retrieval systems at Norfolk Naval Air Station where storage was increased by 400% using 75% less people. • Generated >$100M yearly in sales to commercial customers by offering best service and products for needed applications. • Initiated and successfully negotiated $3B contract for use of “SANDROID” robotic system by cleaning USS John F. Kennedy in 49 days during President Reagan’s Navy build-up. • Negotiated and won >$300M in contracts with other military agencies through skilled proposal submissions meeting Department of Defense contracting requirements AMERICAN MATERIALS HANDLING, INC., Reading, PA Assistant Manager Directly assisted in start-up of first US “Datsun” (Nissan) forklift dealership in America. Performed multiple duties (e.g. Service Technician, Parts Manager, Sales and Sales Manager). Sold >700 forklifts and designed >50 major materials handling systems for industrial and commercial firms in PA, NJ, MD, and DE. EDUCATION • 225 credits towards BSEE and ME (Dual Degree), Lehigh University, Lehigh, PA • AS with High Honors, Electronics Engineering Technology, ITT Technical Institute, Norfolk, VA • LIFE: 50 years’ experience in sales, service, and customer support roles STEVEN ARTHUR STEIN PAGE THREE COMPUTER SKILLS • Microsoft Office / VISIO / Sharepoint • Adobe Acrobat / Photoshop • SOLIDWORKS 2007 / 2008 / 2009 • Lablogic Laura 3 / Laura 4 LIMS • Windows (2000, NT, XP, VISTA,Win7 Pro) • SPC Software (QI Analyst, SPSS) • MRP / ERP Software (SAP, JD Edwards, Peoplesoft, DBA Manufacturing, MAX) • Agile, Oracle ERP PROFESSIONAL DEVELOPMENT • Radiation Safety Officer (RSO) Training, Radiation Safety, Inc. Bethesda, MD • Microsoft MCSE Training (Cert. Awarded), Microsoft • Service Training for HPLC Products, Lab Alliance • Service Training for MeI Stations, GE Medical Systems Uppsla, Sweden • Win 3.1, 95, 98 NT / W2K, XP Server 2000 – 2003, Computer Learning Center, NVCC • Solidworks 2008 Training, Tri-Mech, Columbia, MD • ISO 13485:2003 Training, IBA Molecular N.A. • Professional Certified in Materials Handling, IMMS (now MHMS) • Oracle and Agile training at GE Healthcare, Laurel, MD