Medical Device Engineer
Resume:
Doan Tran
Campbell, CA *****
********@*****.***
Objective:
Seeking a fulltime position at any company in South Bay Area, Northern
California.
Education:
BS in Chemical Engineering.
San Jose State University, California
Focused in Biotech/Pharmaceutical/Medical device fields
Experience:
Familiar with MS Office including Excel, Word, PowerPoint, Out Looks,
Visio, SIMSCI, Perkin Elmer's DSC, DMA, TMA, Haake Rheometer, Thermo
Nicolet FTIR, SEM, FileMaker Pro, Pharmacia HPLC, HP-8453 UV/Vis
Spectrophotometer, Brookfield viscometer, Krebs, Ford Cup and Zahn
viscometer, Titration, HP-5890 Gas Chromatograph, SolidWorks,
Refractometer, Extrusion System (Davis-Standard) for Balloon IBT catheters,
QSR ISO 13485 for medical devices, cGMP, MIL Specs, ASTM, Leco carbon
analyzer and metal laser beam analyzer.
Northrop Grumman, Sunnyvale, CA (12/2006 - Present)
Test Engineer II
I am responsible for the ChemLab that I support the recertification of
shelf life for materials like epoxies, paints, polysulfide, urethane, and
adhesive compounds for internal manufacturing and external engineering
production. I perform the analysis and specification testing on incoming
materials for research and production. I also provide chemical experiments
for various projects to support the Equipment Engineering (MLH), Marine
Logistic Supports (MLS), and Operation. In my responsible areas, I
maintain, revise, and develop current and new written standard procedures
for chemical lab processes that complying with the company quality policy,
MIL Specs, and ASTM. I train technicians on technical processes. I
perform 5S, inventory, and lean manufacturing for the labs.
TenCate Advanced Composites, Morgan Hill, CA (12/2000 - 04/2006)
R&T Associate Engineer
I was responsible for the Analytical Thermal Testing Laboratory that
emphasis in fiber composites and polymers/adhesives. I supported QC, R&D
and Manufacturing in testing and evaluating raw material and finish good
products; or testing and analyzing material on cured profile, viscosity,
glass transition temperature Tg, heat reaction, heat capacity, percent of
cured; and performing the routine assignments for QC. I operated,
maintained and calibrated the analytical equipments. I'd also written the
technical reports and procedures for R&D and QC departments. I worked
closely, provided assistance, and collaborated with scientists, engineers,
QC staffs, manufacturing workers to solve problems and assure customers
satisfaction. I trained Mfg personnel and coworkers for any operation
processes.
Caliper - Pro.Duct Health - Inhale - Scios - LifeScan - AIS
Bay Area (1994 - 2000)
R&D Process - Quality - Mfg Senior Technician
Performed auditing and testing of incoming, in-process, and finished goods
to ensure compliance of specifications for medical devices according to
well-defined criteria using standard physical, mechanical, or electrical
measurement.
Performed validating tools and equipment using in manufacturing and QA lab
to ensure all calibration and maintenance is completed. Worked closely
with engineering and manufacturing group to ensure every aspect is
compliance with design control requirement, and effective inspection and
testing procedure are implemented and maintained. Trained coworkers and
Mfg personnel in any engineering or mfg processes.
Maintained, recorded, and analyzed database for all inspection results,
discrepancy reports, calibration and validation reports, and equipment
history files in an accurate method.
Provided feedback to R&D, document control, and production regarding
procedures, material, and other issues related to the quality. Attended
the operation meeting to report a circumstance of the products, or sub-
assembly, in-coming raw materials, and distribute assignment for the next
period.
Familiar with cGMP, control documents (DHR, SAS, RMS, QSR ISO
13485:DMAIC/DMADV), MS office, tooling, and software.
Performed Lab Chip(R) fabrication including inspection, testing, and
completing finished goods. Performed experiments that involved in cleaning
methods of the drilling holes, the filling process, or eliminated steps for
Lab Chip testing and analyzing, Lab Chip coating process, and multiple Lab
Chip testing. Worked closely with R&D and Engineering to ensure the
procedure is implemented properly; the data is recorded and analyzed
accurately. Provided feedback and assisted Engineering to troubleshooting,
develop tools, and apply correct material for the production.
Maintained, recorded, and analyzed notebook, testing results, and work
orders from internal and external customers. Provided guidance and trained
new members in department. Performed other duties as assigned such as
assisting other group in production.
Familiar with SOP, GLP, Peak Fit software, HP recorder, and in-house
optical reading station.
Performed engineering and detail experiment to collect design data, and
assisted in R&D work for optical testing and medical device malfunction
testing.
Developed diagnostic and qualification methods for module subsystem such as
determine the volumetric extraction technique by using the fiber optic
spectrometer.
Tested the ambient light leakage and electrical noise for medical devices.
Maintained and analyzed the experiment results. Wrote short protocol and
monthly summary reports. Assisted other members, and co-operated with
other groups for company projects or department experiment.
Familiar with SOP, GLP, in-house optical reading station, and other
software to analyze the data.
Performed the formulation of drug and chemical reagent. Operated the
Lyophilized dryer for the pharmaceutical products. Performed the glove box
and the auto-filler CP-2 to measure and fill the insulin powder into the
blister packs as requested.
Set up and operated a Niro spray dryer to produce insulin powder.
Inspected the products, performed and analyzed the moisture content in drug
products. Performed the membrane coating. Tested and organized the data
for the medical device. Assisted and worked closely with R&D and
Engineering department to ensure the procedure is compliance, resolve any
problem occurring, apply and learn new techniques or experiment when it
needed.
Maintained and well kept database, notebook, and reports that relates to
design, material, and processing. Familiar with GLP, GMP, SOP, document
control, batches record review, MS office, software, and any other
appropriated tools in R&D and manufacturing environment.
Built prototype devices and prepared activation and antibody reagents.
Performed the activation and coating cell depletion devices. Performed
FTIR testing on raw materials and products. Assembled in-house designed
device and finished products. Assisted scientist to prepare detail
protocols, experiments, and scale up and transfer new design and product to
manufacturing.
Maintained and analyzed data, reports, and notebook. Attended the group
meeting to demonstrate the experiment and receive a new assignment.
Familiar with GLP, GMP, SOP, MS office, R&D and clean room environment.
Abaxis Inc., Sunnyvale, CA (10/1990 - 10/1994)
Process Technician
Formulated and filtered chemical reagent and buffer solution. Used
spectrometer Shimadzu to test the absorbency of reagent, raw chemical, and
final products. Set up and performed the dispensing equipment. Performed
the moisture analyst on Karl Fisher, and vibration testing for the final
product. Maintained and calibrated laboratory equipment. Order lab
supplies and proceeded water samples to server for testing. Assisted QC
and manufacturing for other assignment such as testing, collect data, and
assemble medical devices.
Familiar with GLP, GMP, documents control, processed laboratory equipment,
and clean room environment.
.
Reference:
Available upon request.
Contact this candidate