Summary: Biomedical Engineering graduate student with experience at leading medical device companies, looking for engineering opportunities in the Medical Device industry
EDUCATION
• Pursuing Master of Science in Biomedical Engineering, San Jose State University, August 2013 –2016 (Expected)
• Bachelor of Science in Biomedical Engineering, University of California, Davis – 2012
SKILLS and ABILITIES
• Knowledge of FDA Quality System and Regulatory requirements per 21 CFR 820 and 803
• Proficient computational skills and scientific/technical writing
• Fabrication - laser cutting/engraving, 3D printing, electro-mechanical assembly, soldering and hand tools
• Database querying and management
COMPUTER PROFICIENCY
• Programs / Languages: SQL (MS SQL Server), SolidWorks, MATLAB (Standard and Image Processing Toolkit), Python (NumPy, SciPy, Pandas), C#, SAP, COMSOL, Excel, Agile, Confluence/JIRA
WORK EXPERIENCE
Graduate Student Researcher, Robotics | Stanford University | August 2015 – Present
• Robotics & neuroscience researcher - Khatib Lab, Stanford University Computer Science department
• Construction of a complex, haptic fMRI robot designed to decipher motor control and coordination mechanisms in the human brain
• Laser cutting, SolidWorks design, lathe, mechanical assembly, 3D Printing
• Electromagnetic compatibility/interference testing (EMC/EMI), component wiring, soldering
• Wiring, testing, calibration of motors and encoders
• Materials/component analysis and buying/purchasing
Complaint Analyst | Medtronic (contracting) | August 2015 – Present
• Investigation and closure of medical device complaints involving pill endoscopy, manometry cathether, and radiofrequency ablation devices
• Ensuring compliance of records per 21 CFR 820 Quality System Regulations and 21 CFR 803 Reporting Requirements
Regulatory Post Market Surveillance Analyst | Intuitive Surgical (contracting) | June 2014 – June 2015
• Database management, query building, report generation in SQL Server - acquired patient, procedure, hospital, system, and instrument data for various purposes.
• Quality monitoring and reporting of RMA and litigation data using SAP, Excel, and Python
• Process improvement – overhauled worldwide failure analysis letter submission to hospitals and ISI distributors
• Performed trending analysis and compiled litigation data for quarterly Alternative Summary Report (ASR)
• Evaluated claim forms and medical records of class-action legal complaints
Medical Surveillance Specialist | LifeScan Inc, Johnson & Johnson (contracting) | May 2013 – June 2014
• Evaluation of potential reportable complaints; submitted Medical Device Reports (MDR) including 3500A MedWatch forms to the FDA and MEDDEV forms to European and Middle Eastern health authorities using Siebel/Oracle databases.
• Gained technical knowledge of LifeScan blood glucose meters and Animas insulin infusion pumps; used statistical analysis to appropriately classify inaccuracy/precision complaints.
MASTER’S COURSEWORK
Current Courses: Medical Image Processing | Regulatory and Clinical Aspects of Medical Devices
Differential Expression Analysis of tumor-related genes in PARP-1 Knockdown Mutants | Fall 2013
• Used Agilent GeneSpring to perform differential expression analysis of mice endocrine tumor microarray data
Simulation of Geometrically-Enhanced Differential Immunocapture (GEDI) | Fall 2014
• Modeled microfluidic immunocapture device fluid flow using COMSOL
EasyNGS | Fall 2014
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