Engineering Manufacturing
Resume:
Objective: To obtain a senior engineering position in the electronics or medical device industries utilizing my 35+ years’ experience and education to improve a company’s manufacturing operations and engineering department.
Strategic Experience
-Training engineering and manufacturing teams
-Development of strategic and tactical documents for senior and executive management
-FDA and Canada Health compliance document experience
-ISO 9001 and ISO 13495 with Canadian Medical Devise Manufacturing experience
-Solve EMI-EMC problems on electronic percussor for Med Systems.
-Solve ESD, EMI and safety issues on humidifiers for Hudson RCI.
Tactical Experience
-Development of engineering documents for FDA 21 CFR 820, ISO 9001, ISO 13485 and Canadian Medical Device Regulation compliance
-Develop manufacturing documents for daily manufacturing team utilization
-Generation of ISO 9001 and ISO 13485 compliance documents.
-Review and upgrading of engineering documents to meet FDA compliance
-Development of test and troubleshoot temperature control boards
-Design thermistor temperature control circuits for test equipment
-Generated documentation of production and support documents for FDA compliance to 21 CFR 820 and ISO 13485.
-Update drawings, improve and maintain quality system.
-Trained production team in assembly, testing and repairs GMP.
-Support production ramp-up of process and product improvements.
-Completed capability and compatibility testing of Electromagnetic Compatibility (EMC) and ETL testing to EN60601-1 of the Electro Flo 5000 Percussor.
-Investigation and resolution of EMC and safety concerns of electronic product.
-Create documentation package for ETL submission.
-Preparation of manufacturing facility for Initial Factory Assessment audit with ETL.
-Obtained certification to EN60601-1 for the US and Canada. Completed audit and obtained ISO certification through SAI Global.
-Testing and troubleshoot of temperature control boards, handheld muscle stimulators, and respiratory percussor.
-Problem solving of manufacturing floor issues.
-Write test procedures for the circuit boards
-Development and testing of initial release product.
-Engineering evaluation of startup product
-Development of minor engineering changes to improve assembly, reliability, testability and repair-ability of product.
-Update designs from discrete logic to Xilinx 9536/72 CPLD
-Design of a 12-key serial keypad and program an 8051 microcontroller in to read keypad and send key code out the serial port.
-Design a remote thermistor thermometer with serial output and program in Keil C51
-Drafted schematics in ORCAD Capture 7.x and compiled CPLDs using Xilinx Foundation 2.1I.
-Miscellaneous design cleanups and drafting schematics in ORCAD Capture V7.
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WORK EXPERIENCE
Engineer
MED Systems, Inc., San Diego, CA Oct 2009 – Current
Support production release, manufacturing
and engineering on Electro Flo 5000
Engineering Consultant (four manufacturing firms) Jan 2007 to Nov 2009
Prowave Manufacturing, San Marcos, CA
Support manufacturing of Muscle Stimulators
Procoat, Inc., San Marcos, CA
Support manufacturing and special projects.
Impact Project Management, San Marcos
Project support.
Outsource Electronics Manufacturing, San Marcos
Manufacturing support.
Engineering Consultant (part time)
KCS INC, Las Vegas, NV. (Startup Company) July 2003 to Dec 2006
Draft PCBs, Mixed signal design, Embedded 8051 software.
Engineering Consultant
Hudson RCI, Temecula, CA Sep 1999 to Jan 2003
Designed ConchaTherm 2000 and released to production.
EDUCATION:
BSEE, CAL POLY, POMONA DECEMBER 1980
AS ELECTRONICS TECHNOLOGY, JUNE 1976
MATHEMATICS, JUNE 1976
POST BACHELOR STUDIES:
Riverside Community College - Spring 2004 to December 2006
Computer Information Systems Classes
Palomar Community College – Winter 2015 to present
Computer Information Systems Classes
ANSI C programming
SOFTWARE LITERACY:
Embedded, 8051, Keil, A51, C, C51, ORCAD, PCB, EMI-EMC, ESD, EN60601-1
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