Sr. Technician

Hoang V. Vu

***********@*****.*** 714-***-****

“Hands on Technical with focus in Medical Device industry”

Extremely hands-on technical with emphasis in testing, troubleshooting and repairing non-compliant products with experience in RGA/RMA (Returned Goods/Material Authorization) and Corrective Action.

EXEMPLARY AREAS OF EXPERTISE

Troubleshooting

ISO Standards

Documentation

Process Improvement

Voltmeters RMA/RGA

Soldering/Rework

Install and upgrade instrument

FDA Compliance

Customer Service Medical Device

Product Assembly

Electro-mechanical testing

Oscilloscopes

Prototyping

RELATED PROFICIENCY

Technical expertise with plastics and electro-mechanical equipment and products.

Experience in using calibration equipment and methods.

Experience in testing and troubleshooting hardware and test fixtures.

EDUCATION

Bachelor of Science – Business Management – SCIT

Associate in Science – Coastline College

Certificate of Electrical Maintenance - Coastline College

University of Phoenix- MBA ( In Progress )

PROFESSIONAL EXPERIENCE

EDWARDS LIFESCIENCES 9/2011 – Present

Engineering Tech

Complete and testing protocol, documentation with minimal assistance

Perform preventive service and repair to equipment, small machinery and manufacturing tools

Assemble prototype devices, test equipment, and tool by verbal or written specifications

Complete projects in a manner consistent with corporate objectives

Support prototype and pilot production of new product, product changes in coordination with Manufacturing and R&D functions

Be able to use test equipment (electrical, lab equipment, manufacturing)

Perform hardware and software testing according to verbal and written specifications

Assist Engineer in product qualification testing by verbal and written specifications

Maintain good knowledge of current process methods, documentation and procedures

Support company goals and objectives, policies and procedures, GMP practices, ISO, and FDA regulations.

Experience with Programming CMM Equipment

Operate Laboratory Instruments and / or Machinery

Experience with CAPA work

Root Cause Analysis

Experience in LabView

BIOSENSE WEBSTER 10/2008- 9/2011

R & D Tech / QA Tech

Under moderate supervision, conduct testing and development activities which require the use of variety of equipment and hand tools.

Uses a variety of precision measuring instruments (Ram optical, Malvern laser, Instron tensile, Laser mike, UV light curing, Multimeter, Power supply, Soldering , Caliper, Flow meter, Pressure gage, Pin gage.

Work under direction of engineers who apply principle of mechanical, electrical and biomedical in the development of products.

Testing protocol/method and execute the test with Good Laboratory Practice.

Ensures that proper documentation is completed for all work with Good Documentation Practice

Strong knowledge in using LabView

Experiences in testing Protocol, DVT, revise and rewrite WI, SOP.

CARDINAL HEALTH 01/2008-09/2008

Technical Support

• RMA Specialist, testing finished product and components, troubleshoot, repair and test sub-assemblies, power supply

• Understanding of GMP and ISO.

• Repair, install and maintain equipment

• Complete upgrade and install hardware of instrument

• Complete technical documentation for all tests.

• Assist the engineer department with reading and interpret schematics and engineering drawings

• Perform electro-mechanical testing after upgrade instrument

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• Experience in lab testing (R and D )

• Soldering and rework

• Provide proficient use of test instruments and tools such as volt meters, digital meter, oscilloscopes, etc.

Beckman Coulter 01/2006-11/2007

R & D Technician/QA Tech

• Install new part into the system

• Testing and troubleshoot system

• Review, run all tests the system

• Complete documentation for tests

• Understanding of GMP and ISO

• Assist the engineering department

• RMA specialist

• Upgrade new system

• Experience in lab testing (R and D)

• Soldering and rework , experience is LabView

EMI MEDICAL 01/2002-01/2006

Engineering Tech

• Test all the product including finished products and components

• Review and run all tests and do complete documentation.

• Assist the quality control department in all analysis

• Perform Capability Studies

Operate Lab Equipment and Instruments

SPC work (statistical process control) (Sampling, chart)

Traceability Documentation

CAPA (corrective action / preventive action)

Root Cause Analysis

HORIZON MEDICAL 02/2000 - 01/2002

QUALITY Tech

• Run and review all the final test

• Document and support the quality control department

• Perform Capability Studies Operate Lab Equipment and Instruments

SPC work (statistical process control)

Traceability Documentation

CAPA (corrective action / preventive action)

Root Cause Analysis

Skills Bilingual: Write, read, and speak fluent Vietnamese.

Reference: Available upon request.

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