Table of contents:

Professional experience:

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Design and Regulatory Consultant for several fortune 500 medical device companies. Product areas include endoscopic RF surgery, arthroscopic shavers, and X-ray camera systems. Over the past two years I have assisted several major medical device companies to engineer their products for compliance with IEC 601-2-2, IEC 601-2-18, IEC 601-1, EN 60601-1-2, EN 601-2-32 and many other standards. In addition, I provide clinical application engineering skills in the field of endoscopic surgery. Some of the RF surgical engineering projects completed include materials testing for insulation, test programs for RF leakage current in clinical settings, and design of test tools for saline packet insulation testing.

As a contract Lead Auditor for TÜV America, Provided domestic and international customers with timely ISO 9000, ISO 13485, EN 46000, CMDCAS and CE Mark registration services. Conducted pre-, initial, continuous and special assessments to assist clients in obtaining and maintaining their registrations and improving their quality management systems. 
       

TÜV Product Service, San Diego, CA, January 97 to September 2000
Senior Product Safety Engineer

• RAB Trained Lead Auditor

• Authorized for audits and safety, performance testing

• General Medical Equipment Safety (EN60601-1) including Dental Equipment, Nebulizers, Pumps

• Particular Requirements for the Safety of High Frequency Surgical Equipment (EN60601-2-2, EN60601-2-18) including RF Generators, Accessories, Endoscopic Equipment, Video Cameras

• Catheters for Medical Use, Ultrasonic Surgical Devices

Valleylab - HPG - Pfizer Inc., Boulder, CO, May 1992 to December 1996
Senior Project Engineer

• Member of CE marking team chartered with implementing all systems necessary for QAS Annex II approval for Valleylab products destined for the European Community,

• Developed several devices for electrosurgical safety during endoscopic procedures. Authored a number of patent listed below,

• Participated in development of ANSI HF-18 Standard for Electrosurgical Devices, ANSI ES-1 Standard for Safe Current Limits for Electromedical Apparatus, through membership in the AAMI HF-18, ES-1 and EMC committees.

Valleylab, Inc., Boulder, CO, August 1989 to May 1992
Project Engineer

• Project management responsibility for electro-surgical systems, including engineering, procurement, manufacturing, planning, and approvals. Secured BSI, TÜV Product Service, GLEM, Sprima, VTT, Nemko, ASA, UL and CSA approvals for many products.

• Co-designed first combined electro-surgical piezoelectric ultrasonic surgical system to comply with IEC 601-2-2 type BF certification as a combined system in Germany and the U.K. Received patent for this work. Patent listed below.

Valleylab, Inc., Boulder, CO, June 1985 to August 1989
Associate Engineer

• Designed an electro-surgical system for high impedance procedures with minimal leakage current. 

• Developed sense, control, power, and safety circuitry for a 500-Watt power   supply and 400-Watt RF Stage to be used in an electro-surgical system. 

• Modified and tested electro-surgical systems to comply with VDE 0871 level B (now CISPR B) requirements for Computing Systems.

Education:

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Bachelor of Science, Electrical Engineering, December 1989, University of Colorado at Denver.
Emphasis on power supply design, linear analysis and application of logic families.

Patents:

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• U.S. Patent 5,190,517 - Electro-surgical and Ultrasonic Surgical System

• U.S. Patent 5,613,966 - System and Method for Accessory Rate Control

• Foreign patents are available upon request

Other qualifications:

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I am a trained, experienced, capable and certified Quality Systems Auditor for compliance with the ISO 9001, ISO 13485 (series) standards, in particular as it relates to manufacturers of soft- and firmware controlled processes and Electro-mechanical medical devices.

Proficient in product design and clinical application of electro-surgery, endoscopic surgery, and ultrasonic applications. Project management,  regulatory affairs,  international medical and EMC standards, power supply design and linear analysis.

Professioanl affiliations:

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• AAMI/ANSI HF18 High Frequency Therapeutic Device Committee

• USA TAG TC62, SC 62A ANSI US National Committee of the IEC