Customer Affairs Specialist
Thoratec Corporation August 2014 – Present
• Apply technical writing skills and engineering knowledge to write investigation report summaries on returned products to Thoratec customers.
• Process complaints for Thoratec HearMate II LVAD, System Controllers, and other products.
Product Surveillance Approver
St. Jude Medical, Inc. August 2013 - January 2014
• Worked as a team to review complaint records to determine the reportability of events to the FDA based on the complaint information, event outcome, and lab analysis report of the products.
• Collaborated with the Product Reporting team to create new and follow-up Medical Device Reports.
• Processed complaints for Pacemakers, Implantable Cardioverter Defibrillators (ICD), and LV and RV Leads.
SKILLS:
Computer:
MatLab, C++, Java, Minitab, Microsoft Word/ Excel/ PowerPoint/ Project/ Access/ Outlook.
Some experience with SolidWorks, LabView, AutoCAD, Pspice Schematics,
Equipment:
Universal Tester, VCA Optima, Bench Grinder, Instron Tensile Tester, Spectral Reflectometer, Bandsaw, Optical Microscope, Laser Cutter, Digital Multimeter, Ultrasonic Transducer, Drill press/Hand drill, Solder machine
TECHNICAL PROJECTS, LABS, AND RESEARCH:
Tremor Quantification Device Development
• Worked in a team of 3 to research, design, document, manufacture, and test a hand tremor quantification device.
• Directed progression of project, ensured collective involvement in decision making, encouraged attention to device specification, assured personal responsibility to my own share of work and lent aid when possible.
Fabrication of PLGA Scaffolds Using Gas Foaming Technique
• Worked in a team of 3 to develop new protocols to fabricate PLGA scaffolds using the gas foaming technique.
• Conducted 5 trials during the project to generate a total of 30 scaffolds for further testing.
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