CHARLES TUTAS

949-***-**** ad26gh@r.postjobfree.com

www.linkedin.com/in/charles-t-46244940 Rancho Santa Margarita, Ca.

Manufacturing & Process Development Engineering Manager

I am a Sr.Manufacturing and Process engineer with over 8 years of supervisory experience and over 20 years of engineering experience in the medical device industry. I am experienced in creating and validating manufacturing processes and equipment. Reduce scrap rates and improve yields by implementing lean Six Sigma manufacturing processes for class 2 and 3 medical devices.

I have experience developing aspiration catheters, microcatheters, guide catheters, guidewires, flow-diverting stents, embolization coils (neuro and peripheral), stents (neuro and peripheral), and the automation and fixturing needed for manufacturing.

SKILLS

Manufacturing Medical Devices; 21 CFR 820, ISO9001, ISO13485 & 14971, IEC 60601, UL 60601, MDR, IPC 610, 620, IPC J-STD-001E, and MIL-T-31000, MIL-STD-100E

Lean Manufacturing; Six Sigma Black Belt, Medical Device Design Controls, MVPs, DHRs, DOE's, PFMEA's PV, TMV, V&V: IQ/OQ, PPQs, POQs, NCRs, CAPAs, and RGAs.

Engineering: AutoCAD, Solid Works, Minitab, Mechanical and Electronic Engineering, PLC programming.

Management; NCO Prepitory, NCO Academy, Project Management, Business Management, Accounting, Contract Management.

PROFESSIONAL EXPERIENCE

Balt-USA., Irvine, Ca. 10/2019 – 9/2022

Sr. Manufacturing Engineer

•Established and maintained production processes and monitored production. Created and executed PD,s NCMR,s, and CAPA,s.

•Established production line layouts, first-pass yield estimates, capacities, and tack times for new and existing product lines.

•Developed the manufacturing equipment qualification systems, including the equipment maintenance SOP, equipment requirements, specification documentation, drawing, and firmware control processes.

•Using Solidworks, I created product design changes to products and developed new production equipment, fixturing, and line layouts.

STACO SYSTEMS., Irvine, Ca. 8/2018 –10/2019

Manufacturing/ Process Development Engineer

•Review existing manufacturing work orders to optimize manpower utilization rates and reduce material variances for existing production lines, reducing costs by 15%.

•Performed and documented failure analysis and root cause investigations of all returned products, saving the company an estimated $175,000 annually.

•Create NCMRs for products and raw materials that do not meet engineering drawings or quality and reliability standards.

MicroVention Inc., Aliso Viejo, Ca. 11/ 2007 – 3/ 2018

Manufacturing Engineer II /Team leader

•I was the direct reporting official for 12 technicians and three engineers.

• The team leader for the company's legacy automation build and maintenance teams. Responsible for planning, scheduling, and producing over 200 pieces of equipment annually. I coordinated the maintenance crews that maintained over 2000 pieces of equipment.

Equipment Design Engineer II

•Created over 20 equipment designs, including semi-automated tabletop tube-necking and fusing equipment and complex free-standing tube-necking, reflow, and coating towers.

•Standardized all automaton designs into four base machine designs, reducing average machine cost by $6700 per machine.

Manufacturing Engineer

•Created and completed NCMRs for products and raw materials

•Performed and documented failure analysis and root cause investigations for field returns for all MicroVentions embolic coil systems, microcatheters, and guidewires products.

Abbott Vascular, Temecula, Ca. 4/2005 –11/ 2007

Manufacturing Engineer Associate

•Production line engineer for the company's first Lean Six Sigma production line.

•Perform time and motion studies to establish production rates and manpower utilization and determine material variances for the Lean Sigma production lines.

•Reviewed lean manufacturing procedures and work orders to verify assurance of the company's quality specifications.

•Created a Lean Sigma scrap database and engineering project creator.

Avail Medical Irvine, Ca. 2/2003 – 12/ 2005

Associate Manufacturing Engineer

Masimo. Irvine, Ca 10/1997 -10/2000

Manufacturing Engineer

RAM Optical Company, Inc. Huntington Beach, Ca 2/1994 -10/1997

Sr Engineering TechnicianSr Engineering Technician

Teledyne Systems Company. Northridge Ca. 9/1990-1/1994

Sr Engineering Technician

United States Air Force 7/1983 -7/1989

Missile Systems Specialist. Staff Sgt

EDUCATION

Irvine Valley College, Irvine, CA 8/2000 -12/2005

AA, Business Administration

Irvine Valley College, Irvine, CA 5/2005-6/2009

Mechanical Engineering

Core classes completed, transferring to UCI.

University of California Irvine, Irvine, CA. 5/2007-6/2010

Project Management

Community College of the Air Force

Missile and Space Systems Technology 7/1985-3/1989

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