Medical Device Assistant

AARATHI KRISHNA

*** ***** ***** ******, ****** IN 46582 * 267-***-**** * ***********@*****.***

EXECUTIVE SUMMARY

Extremely innovative and result oriented professional with a strong educational background on biomedical engineering, medical device development and medical device quality system. Demonstrated working knowledge of 21 CFR Part 820, ISO 13485 and ISO 14971 in a regulated medical device industry. Possesses hands on experience on thoracic and pelvic reconstruction using MIMICS and 3D Slicer. Skilled technical protocol and report writer incorporating quality tools and statistical programs like Minitab. Brings a commitment to growing and learning, a passion for problem solving, and working independently as well as cross functionally. PROFESSIONAL EXPERIENCE

ZIMMER BIOMET, WARSAW IN

Contract Development Engineer - Project Polaris (Hip group), November 2017 – Present

Perform DHF/DHR remediation of existing hip implants and instruments in accordance to requirements set per 21 CFR Part 820 – Quality System Regulation

Prepares definitive new product specifications and/or modifies existing specifications

Review existing DHFs, identify scope and perform Gap Analysis and Gap Closure for the medical devices based on their design inputs. Analyze critical, major and minor gaps

Generate comprehensive protocols, assessments and reports to test/analyze the product and design assurance documentation for the project

Perform statistical analysis using Minitab in generating the number of samples to be used for testing

Develop test method validations for the mechanical testing of implants/instruments

Author technical reports (Engineering Justifications, Memos, DVATs) to close verification gaps and perform root cause analysis

Developing DCTMs by identifying user needs, design inputs, design outputs and design verification and validation.

Collaborate with development, design, quality, and regulatory teams to update the current design controls of hip instrumentation to meet the FDA requirements

ORTHOPEDIC BIOMECHANICS LAB, DREXEL UNIVERSITY, PHILADELPHIA PA Graduate Research Assistant, April 2017 – October 2017

Research and study methods of calculating Hounsfield Unit (HU) values confined to lumbar and thoracic vertebrae of pediatric population (1-18 years)

Perform image analysis on the pediatric CT scans measuring HU values for both males and females using MIMICS 16.0

Acquire and compile CT numbers from scans, calculate mean HU corresponding to different ages

Study relationship between Hounsfield unit values and age groups using MATLAB; perform statistical analysis based on the HU values obtained

Pelvis and thoracic reconstruction for normal and scoliotic patients in the pediatric population at the Children’s Hospital of Philadelphia

(CHOP)

Prepare reports on the results of the research and the reconstruction using word processing, spreadsheet, database, or presentation software DEPARTMENT OF PHYSICS, DREXEL UNIVERSITY, PHILADELPHIA PA Teaching Assistant, April 2016 – June 2017

Conducted laboratory experiments on Fundamentals of Physics I, II and III, trained students to solve problems associated with subject

Supervised undergraduate students in handling apparatuses in laboratory environment and their troubleshooting with utmost care and in a safe environment

Developed and maintained constant communication with the professor, fellow TAs and the students

Reviewed and evaluated students' progress in relation to the individual laboratory performances ORTHOPEDIC BIOMECHANICS LAB, DREXEL UNIVERSITY, PHILADELPHIA PA Research Intern, July 2016 – September 2016

Captured spinal cord images of healthy and unhealthy rat slides subjected to different kinds of staining (CGRP, 5HT, GAD) using Fluorescent Microscopy

Performed image analysis on rat files using ImageJ software

Researched and studied correlation between CGRP, 5HT, GAD staining in rats undergoing intervention and without intervention

Prepared reports and compiled data to plot graphs showing the relationship using MS Word and MS Excel

Protocol preparation listing detailed set of activities and instructions to be followed while performing experiments EDUCATION

MASTER OF SCIENCE IN BIOMEDICAL ENGINEERING, JUNE 2017 Drexel University, Philadelphia PA

BACHELOR OF TECHNOLOGY IN BIOMEDICAL ENGINEERING, APRIL 2014 Cochin University, Kerala, India

CERTIFICATIONS

Quality Systems Regulation (QSR) and Good Documentation Practices (GDP) provided by Zimmer Biomet

Lean Six Sigma (Green Belt) Certification issued by Expert Rating Global Certifications

Corrective and Preventive Action (CAPA) training issued by iLearn, Learning Management System provided by Zimmer Biomet

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