Leon Shargel, I.E., CmfgE

**** *. ******* ***.

Phoenix, Arizona 85032

480-***-****

acs8sx@r.postjobfree.com

A certified Mfg. Engineering Manager and LEAN Six Sigma Master Black Belt

Qualifications:

Certified Lean Six Sigma Master Black Belt - Manufacturing Engineering Manager with over 20 years of experience leading production facilities in manufacturing, production and assembly.

My professional career began at Johnson &Johnson, where I was promoted to engineering manager in September, 1990 of the pacemaker and battery divisions at, Cordis-Telectronics division of J&J where I worked for over 15 years.

Bendix Avionics-Allied Signal Aerospace (Honeywell) Fort Lauderdale, FL Manufacturing Engineering Manager, responsible for the supervision of the tool-room, machine shop and robotic weld, plasma spray and brazing production lines for aerospace and oil & gas downhole components. Designed tooling, fixtures and directed the programming of numerous CNC machines.

Senior Manufacturing Engineering Manager in the Tempe and Singapore global headquarters of MMI Industrial Manufacturing division – KKR Venture Capital Partners (J&J)

20 years plus experience in the management of manual, semi and automated processes in machining, flame spray (plasma) wear coatings, and mechanical assembly, CNC machining, Fanuc and ABB robotic laser welding and plasma spray coating (Union Carbide, CSI, Stork and Spraymation) sheet metal stamping/forming – single station & progressive die design plus my certification as a Journeyman Toolmaker, gives me an edge in manufacturing and in leadership.

I am qualified, experienced and certified in Solidworks, SolidEdge, ProE, NX7.5, Autocad Inventor, MasterCam, TopSolid, CREO, ASME Y14.5M, CAPA, CGMP, C.A.M.P., DOE, NPI, FEA (COSMOS), D/PFMEA, DFM, DFSS, TQM, TPM, DMAIC, SPC, T-Six, APQP, PPAP, ISO9000, FDA, FAA, IQ, OQ, PQ validation protocols. Certified ISO 9001 Team Captain, ISO 13485, AS9100C.

March 23, 2015 – September 25, 2015, Medtronic – Covidien Minimally Invasive Therapies Group, Deland Florida, Oxford Global Resources

Manager of Process Improvement Engineering (consultant)

Process improvement of existing automated syringe assembly machines

NPI for two new syringe automated robotic assembly systems

Responsible for DHR documentation on several projects

Machine, process and production validation, IQ, OQ, PQ

January 2006 to January 20015, Phoenix, AZ facility. I was transferred on

April, 2011 to the Singapore Global Headquarters of MMI

MMI Industrial Mfg. Group, KKR Venture Partners, J&J Subsidiary Partner, Director of Manufacturing Engineering

Directed engineers, machinists and toolmakers involved in the manufacturing processes of medical devices, aerospace and oil & gas components for markets in Europe and Asia.

Managed the engineering group of 27 engineers and a total employee population of 280 skilled tradesmen.

Obtained NADCAP certification.

Implementation of LEAN Six Sigma methodologies, value stream mapping, discrepant material reduction and design for manufacturing processes for all CNC turning, milling, fluidic system design/build, plasma spray coating (Inconel, D17, Hastelloy, Monel forgings, castings and downhole tooling.

Mentored Six Sigma training programs, SMED and Kaizen events. Improvements that optimized programs and tooling design which significantly shortened cycle time.

Developed live tooling and fixtures for QA and machined part inspection.

Design and develop production manufacturing processes and tooling for medical devices, avionics components for fixed and rotor wing aircraft and downhole exploratory technologies for oil & gas components for Honeywell, Boeing, Bombardier, Parker Hannefin, Johnson & Johnson, B&D, Schlumberger, Halliburton and more.

Designed original automated flame spray gun for nickel, Inconel, zirconia and wear coatings including Teflon.

Trained operators in the MPOB system, certified 9 six sigma greenbelts and mentored 3 black belts, implemented a Lean 5S program.

August 2001 - January 2006

EFTC div. Bendix/Allied-Signal/Honeywell, Ft. Lauderdale, FL, Phoenix, Arizona, Manufacturing Engineering Manager - Systems Integration Division

Lead design and fabrication team developing automated production equipment and assembly processes and tools for machined aerospace products (rings, blades, vanes and precision ducting. Evaluate materials selection, engineered speeds, equipment temps, pressures and force calculations.

Developed IQ, OQ, PQ validation processes for prototype machining (first article).

Participated in ramp-up of two pilot avionics projects (NPI)

Obtained Six Sigma Black Belt certification in 2000, Master Black Belt in 2003.

Purchased and validated state-of-the-art cleaning systems, three Citizen Swiss automatic CNC machining centers and 20 Fanuc welding robots.

Responsible for design/build team leadership in high speed automated mfg. and assembly.

October 1982 – August 2001

Johnson and Johnson, Cordis division, Miami Lakes, Florida, Manufacturing Engineering Manager (1990)

Developed the Gemini Pacemaker stamped hydro-formed shell production process.

Implemented SPC and FMEA programs and captain of ISO 9001 team

Developed new stamping process D.O.E.ʼs for the Gemini pacemaker

Developed tooling and product development of biopsy forceps, stents, shunts,

Special projects engineer in the pacemaker battery division.

Member of the patent team for the “Infustat” monitor & Gemini.

Received my FDA CGMP certification in 1991.

Won the Johnson & Johnson President’s Award for cost saving initiatives and the Shigeo Shingo award for Poke Yoke implementation.

Awarded the State of Florida ReWrap award for TCE waste reduction.

Wrote and executed numerous IQ, OQ, PQ validation and qualification protocols.

Implemented DFM for new molds, CNC programs and qualification of Marubeni Citizen – Star and Tornos-Bechler Swiss automatics.

Accomplishments and Certifications:

Graduated B.S.I.E., Florida Atlantic University 1982

Training Certification- FMEA, TQM, TPM, IQ/OQ/PQ, DFMEA, PFMEA, DFM, DFSS, FEA (COSMOS), CGMP

Certified Lean Six Sigma Master Black Belt - Allied Signal/Honeywell, University of North Florida, 2003

Certification: DMAIC, Kaizen, KanBan, Lean, Solidworks, ProE, AutoCad, Mastercam, CREO, GD&T, ANSI Y14.5M

Certified programming and operation of numerous CNC platforms in turning, milling, grinding, Swiss automatics and screw machines. Citizen, MoriSieki, DMG, Doosan, Miltronics, Doosan, Haas, DMG and Heidehein palletized tombstone multiple fixture machining.

Training Certification: Arburg, Battenfeld, Cincinnati Milacron, Fuji, Graham/Sidel Injection and blow molding systems

Training Certification - MiniTab, LabView and Datamyte, DOE and SPC, Q1 Macro

Certified ISO 9001 Team Captain, ISO 13485, AS9100C

Microsoft office and analytical programs, (Word, Excel, Power Point, Project, etc.)

Certified developmental designer/programmer – Fanuc, ABB and Si/Bot robotic platforms.

TPS, Shigeo Shingo, Demming management school graduate (2000)

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