Engineer Mechanical Engineering
Resume:
Irene S. Shu
**** ****** ****, *** ****, CA *****
*****.***@*****.***
OBJECTIVE
A full time position in the manufacturing or product development of medical devices.
EDUCATION AND STUDY
Master’s of Science in Mechanical Engineering – currently pursuing
San Jose State University, California
Bachelor’s of Science in Biomedical Engineering June 2007
University of California, Davis
GPA: 3.44
ENGINEERING EXPERIENCE
Abbott Laboratories, Vascular Division; Redwood City, CA August 2008 through January 2009
• Consolidated and optimized documentation of stock to final product assembly for more
than 15 products.
• Developed precision production time studies and reports for manufacturing improvement.
• Was responsible for developing final visual inspection criteria for refrigerated stent loading
process.
Boston Scientific Corporation, Peripheral Intervention; Cupertino, CA July 2007 through July 2008
• Became on site expertise for process validation, product qualification, and microbiology
requirements related to EtO sterilization revalidation activities.
• Managed a Corrective and Preventative Action (CAPA) project to establish compliance
with corporate and industry sterilization requirements.
• Conducted biocompatibility studies and design verifications for a material change in
response to a Product Inquiry Report (PIR).
• Organized and presented training to all areas of the business for manufacturing, inspection,
and standard operating procedures.
• Determined and communicated effect of design changes on EtO sterilization.
• Organized sterilization and environmental monitoring trend documentation to reduce inpact
on productivity of FDA, TUV, and California State audits.
• Collaborated with a cross functional group to expand the Process Failure Mode and Effects
Analysis (PFMEA) for the stent delivery catheter.
TECHNICAL SKILLS
Working knowledge in the following computer aided design programs to carry out
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modeling and finite element analysis: SolidWorks, CosmoWorks, Pro/Engineer, and
Pro/Mechanica.
Skillful in text, spreadsheet, and presentation design using MS Office.
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Proficient at using MS Visio to develop flowcharts and diagrams.
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Basic mechanic shop skills such as machining using the lathe, mill, and drill press.
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Operational knowledge of Instron and digital microscopes.
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HOBBIES
Motorcycle riding, Swimming, Swim Instructing, Kickboxing, Snowboarding.
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