Warsaw IN, 46580
407-552-8647
Newton
Education
University of South Florida Tampa, FL
• Master of Science in Engineering, Biomedical Engineering May 2014
• GPA:3.37
The University of Alabama in Huntsville Huntsville, AL
• Bachelor of Science in Engineering, Mechanical Engineering May 2012
• GPA:3.04
Oakwood University Huntsville, AL
• Bachelor of Science, Applied Mathematics, Minor, Biology May 2012
• GPA:3.21
Summary of Qualifications
Over 3 years of experience gained through industry and internships with 1 year and 9 months in the medical devices industry. Experience working in a cross-functional team that including design engineers, manufacturing, regulatory affairs, and other team members to develop product requirements on existing products. Extensive experience with quality system regulations (QSR), and good manufacturing practices (GMP), ISO quality requirements, and design history files (DHF). Experience includes:
• Corrective and Preventative Action • Anatomy and Physiology
• Statistical Analysis Methods • Verification and Validation
• Geometrical Dimensioning and Tolerance (GD&T) • Statics and Dynamics
• Design Failure Modes and Effects Analyses • Feature Inspection Plans
Skills
Microsoft Office, AutoCAD, SolidWorks, Solid Edge, MathCAD, MATLAB, Nastran, Patran, SAS Statistical Software, JD Edwards, Stellent
Experience
Oct 2014-Present Zimmer Warsaw, IN
Development Engineer
• Successfully contributed to the remediation of Class I & II medical device design history files (DHF) on or prior to scheduled closure date
• Effectively used GD&T training to verify proper tolerancing and dimensioning on part prints and layouts
• Used knowledge of quality system regulations and ISO 13485 quality requirements ensure compliance of orthopedic knee implants with FDA regulations
• Reviewed Design Control Traceability Matrix (DCTM) to ensure device specifications conform to surgeons needs, and intended uses
Feb 2013-Apr 2014 Fluorometrics Instruments LLC Tarpon Springs, FL
Research & Development Engineer Paid Intern
• Effectively decreased the response time of Oxygen and pH biosensors below competitors through experiments and statistical analyses
• Conducted experiments which successfully reduced the cost of pH Sensors
• Industriously performed troubleshooting procedures on out of calibration equipment, fiber optics sensors, and pH patches
May 2013-Aug 2013 CIH Equipment Inc Clearwater, FL
Quality Control Engineer Paid Intern
• Ensured compliance with ISO 17025 by conducting an internal audit, modifying company policies and procedures, establish metrological traceability, and performing root cause analysis which resulted in the companies reaccreditation
• Effectively wrote and improved SOPs, and modified Quality Manuals and other regulatory documents
• Design and implement a comprehensive maintenance and calibration plan for industrial hygiene equipment
Aug 2011-May 2012 University of Alabama in Huntsville Huntsville, AL
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