Professional experience:
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JM Resources, San Diego, CA,
September 2000 to Present
Principal Engineer
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 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,
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.
Professional 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
