Engineer Medical Device

KEN JUDA

*** * ******** ***. ***#D**, Campbell, CA 95008

858-***-**** • *******@*******.***

PROFILE

Over 8 years of engineering experience in various aspects of the medical device, refrigeration and automotive industries; including product development, product design, product planning and production. Mechanical Design Engineer with sophisticated project engineering skills and rich in international experience, currently working as a Product Engineer at a leading medical device company specializing in the histopathology industry.

EDUCATION

University of California, San Diego, B.S. in Mechanical Engineering, 2003

University of California, Irvine, Medical Product Development Certificate, expected December 2012

TECHNICAL SKILLS

• Inventor2010 • AutoCAD2010 • SAP

• SolidWorks • Microsoft Office • Pro-E

• Oracle Enterprise Manager

EXPERIENCE

Jan 2011- Present Product Engineering Department, Sakura Finetek USA Inc., Torrance, California

Product Engineer, Level II:

Performed engineering assignments to support electromechanical instruments by providing technical expertise via trouble shooting and failure analysis. Conducted engineering investigations of histopathology medical devices involving calculations and/or tests in support of current products, products under development, new methods, new materials and process studies. Provided engineering oversight for Tissue Processors, Paraform Embedding Machines and Slide Coverslipping Instruments.

• Appointed to be in charge of the support and improvement of the latest generation of the bestselling product, Xpress x50 and x120 Tissue Processer, along with other instruments conforming to UL 61010 and ISO13485 standards.

• Investigated and found the root causes of field failures and implemented Corrective and Preventive Actions (CAPA) to comply with FDA regulations.

• Communicated design faults and advised new designs to the R&D Department.

• Supervised the testing and coordinated the revision of UL Listing Reports of listed instruments.

• Conducted UL standard tests such as input test, dielectric strength test, current leakage test, etc.

• Conducted product testing and software validations to verify design compliance.

• Conducted field services escalated from the Service Department and successfully troubleshooted and repaired faulty instruments.

June 2005-Jan 2011 Corp. Engineering Department, Panasonic Corp. (Previously Sanyo E&E), San Diego, California

Design Engineer / Project Leader:

Designed and developed engineering drawings for household refrigerators/freezers, vending machines,

showcase refrigerators, and biomedical refrigerators. Ensured that designs met all government

regulations, safety and industry standards and customer preferences. Created assembly drawings,

including bill of materials, detailed drawings and instructions of assembly. Design and fabrication in

plastic injection molding and plastic extrusion parts (ex: ABS, polystyrene, polyproprene, PVC,

polycarbonate), sheet metals (PCM, stainless steel, galvanized steel), and rubbers/polymers (polyurethane, EPDM, polyethylene, EPS). In charge of structural, endurance, safety and energy testing of individual components and finished product in order to meet regulations and industrial requirements.

• Designed and developed products for Fortune 500 clients such as Whirlpool, Maytag, Sears and Walmart.

• Re-designed and modified existing tooling to better enhance and improve on existing models

• Facilitated with suppliers/venders during the development of components

• Supervised product assembly and quality of product at the production facility located in Tijuana, Mexico

• Project Leader for new high end under-counter appliance refrigerators and beverage centers

• Lead a 4 member team in the development of a biomedical refrigerator and freezer for hospitals

• Tested, developed and created specifications for a newly designed AC condensing fan motor

• Coordinated between U.S., Mexico and Japanese staff in completing projects

Nov 2003- Mar2005 Production Control Department, Kyowa America Corporation, Tijuana, Mexico

Project Engineer, Production Control Department

• Worked at a major Mexican manufacturing plant for a Tier One supplier to Toyota Motor Corporation for the newly redesigned Toyota Tacoma.

• Managed and coordinated Production Scheduling of all raw materials and finished products. Monitored supply chain management with the implementation of the Toyota Production System.

• Implemented Total Quality Control (TQC) within the production plant.

• Chosen trainee to participate in an intensive 3-month training program in Toyota city, Japan from January 2004 to March 2004

ADDITIONAL INFORMATION

• Language: Japanese (professional level) and Spanish (proficient)

• Standards: UL61010 (Electrical equipment for measurement, control and laboratory use), FDA (21 CFR 820), UL250 (Household refrigerators/freezers), CSA, AHAM, Department of Energy regulations, ISO13485, ISO9001, ISO14001, NSF, IEC60335, GMP and ASME standards

• Certificates: NSF training completion, Autodesk Inventor (intermediate level), EPA level 1 refrigerant handling

• Programming: C++, Labview, Matlab and Basic Stamp (1 year)

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