Engineer Quality Control

Jesus W. Hernandez

***** ***** *******, ***. ****

San Antonio, TX 78230

830-***-**** *****.*.***@*****.***

PROFESSIONAL EXPERIENCE

BioMedical Enterprises Inc., (San Antonio, TX) May 2013 - March

2014

Engineer

. Performed materials and mechanical bench testing according to ASTM

standards on nitinol medical devices

. Prepared test fixtures to assist with mechanical testing of bone

staples and plates

. Prepared and managed validation processes (IQ/OQ/PQ) for manufacturing

equipment and design software

. Followed FDA Guidance on Design Controls while managing current and

future projects

. Assisted with 510k regulatory submittals

. Prepared SOPs for current and former testing methods

. Performed Risk Assessment Analysis studies under ISO 13485

BioMedical Enterprises Inc., (San Antonio, TX) March 2013 - May

2013

Production Technician

. Assisted in assembling, shipping, storing, and packaging of nitinol-

based orthopedic devices

. Performed and documented in-process and final inspections of

orthopedic medical devices

Kinetic Concepts Inc., (San Antonio, TX) July 2012 -

November 2012

Biomedical Engineer Intern

. Assisted in research and development experiments for the PrevenaTM

Incision Management System

. Followed existing SOPs to perform mechanical testing of biological

tissue, analysis of test results, and preparation of a final report

. Assisted with quality control/assurance to ensure that data had been

recorded and saved appropriately

Biomaterials Lab, UT-San Antonio, (San Antonio, TX) May 2008 -

December 2011

Graduate Research Assistant

Participated in multi-scale research projects involving the

preclinical development of calcium phosphate scaffolds for military

personnel with significant craniofacial or limb damage

. Processed bone scaffold specimens using tissue histology and

histomorphometry techniques

. Prepared written articles and poster presentations for journal and

conference publications

Southwest Research Institute, (San Antonio, TX) September 2006 -

December 2006

Laboratory Technician

Analyzed hydrocarbons/fuels to ensure ASTM research standards were met

prior to commercial use

EDUCATION

The University of Texas at San Antonio (UTSA) & UT Health Science Center at

San Antonio (UTHSCSA), San Antonio, TX

. M.S. in Biomedical Engineering 2011

St. Mary's University, San Antonio, TX

. B.S. in Biology 2006

. Minor in Chemistry

COMPUTER SKILLS

JMP ? Sigmastat ? Solidworks Essentials Training ? Microsoft Office Suite ?

Matlab ? ISOXpress

LABORATORY SKILLS & TECHNIQUES

Mammalian cell culture ? Fluorescence microscopy ? Histology ?

Immunohistochemistry ? PCR ? Luminex Assay ? FT-IR ? XPS ? SEM ? MTS ?

Goniometry ? 100R PC Based Modular Test System ? Histomorphometry

ASTM TEST METHODS

ASTM F382 ? ASTM F2082 ? ASTM F1264 ? ASTM F564

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