Data Entry Clean Room

PHI TRUONG

**** ****** ***, *** ****, CA *****,

Email :**********@*****.***

Phone : 408-***-****—Cell phone 408-***-****

Objective

A challenging position in manufacturing environment where I can use my abilities,skills a Experiences as an Electronic mechanical Assembler/Tester, medical device industry, Inspector.

SUMMARY OF QUALIFICATION

Skills

• Medical device assembler with over fifteen years related experience

• Excellent manual dexterity and ability to assemble medical products using a microscope and small hand tools

• Proficient at multiple assembly tasks while meeting requirements for workmanship, safety and productivity

• Operational knowledge, heater boxes, programmable ovens, UV Omni-cures and functional testing equipment

Experience working within an R&D lab and clean room environment

Experience assembling and inspecting small parts on medical devices

Experience following SOP’s and GMP’s

Experience working closely with engineers to resolve quality issues and suggest improvements

Experience with mechanical small parts and various hand tools and microscopes

Highly organized and experienced with documentation

Worked closely with engineering throughout my career in an R&D environment

EXPERIENCE. :

Spinal Kinetics 5/ 2017 To 1/ 3/ 2023

Work with Engineers and Technician to resolve line issues and suggest improvement

Proficient in basic assembly procedures. Cross-trained in two or more product areas.

Read, understood, and followed written instructions. Documented parameters/information on documents or Lot History Records

Used assembly tools such as tweezers, wire cutters, screwdrivers, and mandrels. Measured medical device parts using calipers, height gage meters, micrometers,

Assemble plastic and metal components into medical devices in accordance with approved manufacturing procedures

Work on assignments outside production (Engineering Build Request/R&D)

Utilize small hand tools, calibrated instruments, measurement equipment, microscopes, and test fixtures.

Accurately document all required entries in the Lot History Record (LHR).

Adhere to general safety rules, manufacturing procedures, company policies and procedures, ISO, QSR, and FDA regulations

Completion of cross-training in three or more product areas is required

Perform in-process quality checks on sub-assemblies and finished product

Comply with GMPs with regards to material labeling, SOPs and proper segregation of material in the production process.

Structural Heart / Boston Scientific 8 / 2016 ---2/ 2017

Perform inspections of parts under microscope to ensure product quality

Follow all safety procedures, wearing requisite clean room garb and protective gear in clean room environment

Follow documented work procedures, perform line clearance and accurately document production activities in accordance with GMP requirements

Using fixtures and tooling, sew small components together under a microscope in a clean room according to manufacturing instructions, standard operating procedures and safety policies

Will be required to worked under microscopes, work in a clean room environment,

Assembling small parts under a microscope for extended periods of time

Tissue handling experience

Record information on DHR (Device History Record

Must show proficiency manipulating small parts with tweezers, microscopes, etc.

Comfortable working with a microscope for full shift if needed

Creganna tactx medical - R & D Lab 11 / 2013 8 / 2015

I help in building a sheath and catheter using braiding, coiling, laser welding, hotbox, heat shrink, sanding equipments. And also using small hand tools and electric tools

microscope. I also help in assisting engineer in design services. I work on products that been built in cer, work in R&D lab

Worked with engineers in building and testing prototypes and new product development.

Read work instructions and precisely operator equipment or processes per documented procedures.

Performs in-process quality checks on sub-assemblies and finished product.

Utilizes small hand tools, calibrated instruments, measuring equipment, microscopes and test equipment.,UV Cure Welding Laser Welding

Works with engineers and technicians to resolve line issues and suggests improvements.

Constantly segregates parts for lot, size and defect types.

Maintains accurate records / documents related to quality, work in process, test results, labor and special projects.

Adheres to safety rules, manufacturing procedures, company policies and procedures, and Good Manufacturing Practices.

Works with teams to standardize products and processes.

Understanding of GMP, GDP

W.L. Gore Assoc, Inc - 6/2006 --- 10/2013

Perform assembly of fine pitch components utilizing a microscope and tweezers.

Perform with Caliper, Ruler, and Pin Gage .

Use hand tools and follow written and oral instruction

Perform assembly, complex and repetitive wiring to complete sub-assemblies and final assembly of product.

Perform techniques such as winding, sewing, bonding, assembly, cleaning, cutting, packaging and inspection.

Inspection parts to use caliper or under microscopes

Working to standard operating procedures, bill of materials, manufacturing information, and instruction from Production Supervisor..

Working in medical device clean room environment

Working in class 10,000 Clean room environment wearing protective garments

Curon Medical, Inc - 04/2005 – 4/2006

Responsible for building Catheter including soldering wire to wire, also attached balloon to Catheter

Performed incoming and in-process quality check of component, Sub-Assemblies and finish products

Performed use various intricate tools such as tweezers, cutters, pliers, leak tester, hi-pot tester, and simple assembly fixtures; and be able to inspect under a microscope.

Tin-Soldering the wire – RF needle connector – soldering the ball for TC needles

Build light-pipe by used Hot-box to melt the pipe, also to do the Hybrid needles

Cordis Corporation - 2000 - 3 / 2005

Manufacturing Associate ( Assembler II ) and Machine Operator

Performed inspection of stents accurately as per quality control procedures; visual inspection of lot, manually debur and deslug, usage of mandrel to test stent, utilized heat treatment to test stent in salt pot, cleansed stent further in sulfuric acid, completed polishing of stent, tested the stent under various heat temperatures to check the diameter and completed another round of visual inspection under a microscope to meet various industry standards

Produce medical device products such as catheters, guide wires, PTCA balloons, stents

Using Micro Meter, Caliper, Snap Gauge, No-Go Gage and Pin Gage. Measurements using micrometer, dial caliper, snap gauges, pin gage, and other measuring instruments. –

Experience with Stent/ Nitinol processing with salt baths, honing, expansion and electropolishing stations and other Nitinol-related equipment..

Performs the Visual inspection under microscope of stents & filters, dimensional inspection of stent

Performs the Smartscope to measurement of stents and filters..

Must have Visual acuity using the optical microscope.

Completed basic production, health, safety and environmental hazard training courses.

Communicate problems to Supervisor, Technician or Engineer .

Works at different work station as production needs require.

Works with Engineering and Technician in pilot run of assemblies.

Working in class 10,000 Clean room environment wearing protective garments

Lifescan—Militas - Assembler ( 1997 – 2000 )

Performs as manufacturing associate with daily production goals at One Touch.

Manufacturing area, Computer, Assembly, Packing section performed by TQC, MQSI.

Production goal with quality interface One Touch products.

3 – Com Corporation - Assembler ( 1996 – 1997 )

Soldered connectors on to PCMCIA board, testing, board at all levels.

Labeled PCMCIA cards and packaging for shipment.

Assembler networks stackable hubs and for final test before packing.

Final and subassembly production with packing and training support audit works.

Education :

Electronic Assembly Certification at Vocation Training .

Associates of Arts in General Education - Viet Nam.

Computer Skill :

Basic use of Excel, data entry etc.

Reference: Available upon request.

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