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Engineer Medical Device

Location:
Attleboro, MA
Posted:
December 10, 2020

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Resume:

Teja Karra

Product Development and Testing Engineer

Phone:

248-***-****

Address:

**** ******* *****

Troy, MI 48083

LinkedIn:

www.linkedin.com/in/saratteja-karra

Email:

adikdp@r.postjobfree.com

Residence:

US Citizen

I am an engineer and certified EI/EIT with over two years of experience in the medical device industry. I have worked in product development, testing, and the FDA design controls process, specifically in the spine and sports medicine sections of the industry. I am an outgoing and driven professional with a strong passion for technical problem solving and taking on new challenges. My interests include orthopaedic biomechanics, solid mechanics, computational modeling, statistical and numerical methods, product development, testing, medical device design, and V&V design activities.

Experience

DePuy Synthes Spine

April 2019 - September 2019

Research and Testing Engineer

Contract Employee from Kelly Services

Worked on product development, design verification, and test method validation in the Research and Testing Group

Interfaced with product development team for FOX surgical visualization project, working on development of instrumentation for surgical navigation with intra-operative imaging of spine procedures

Served as direct liaison and representative of R&T group to product development team, coordinating testing program between groups

Provided testing expertise to product development team to develop testing protocols for best utilization of mechanical testing capabilities and for correct statistical methodology and DoE

Performed linear and rotational testing for yield and ultimate failure conditions in both static loading and dynamic fatigue loading with Instron electromechanical testing equipment

Tested FOX product prototypes development, as well as existing Viper Prime pedicle screws and other instrumentation

Developed and implemented new testing method for assessment of migration of navigation instrumentation during surgical procedures using fluoroscopy and CT image segmentation and analysis

Zimmer Biomet

June 2017 - December 2018

Development Engineer

Contract Employee from Modis IT & Engineering, a subsidiary of Adecco Group

Worked from project initiation through completion on design remediation of sports medicine implant products

Remediated design history files (DHFs) of suture anchor and interference screw products per corporate design controls procedures and FDA quality system regulatory standards

Assessed current design input and output documentation and establishing new predicate structures based on indication and testing requirements

Wrote and executed static, dynamic, fatigue testing protocols for design verification, with a focus on test method validation and statistical methodology with Minitab

Conducted engineering analysis of products, including section analysis and finite element analysis (FEA) with NX to assess worst-case failure mechanics of implant and instrument products

Developed new test fixturing and modified existing fixtures for novel testing methods and reconfigured load cells to accommodate these methods

Utilized failure modes and effect analysis (FMEA) to assess adequacy of risk control methods for design and usage of implants and instruments

CareTech Solutions

June 2016 - October 2016

Service Desk Agent

Provided first-level technical support to healthcare professionals for standard hardware and software problems and troubleshooting issues with Epic electronic medical records

Worked with ticketing and documentation of problem and service calls as well as escalation of service

Wayne State Bioengineering Center - Human Modeling Lab

May 2014 - August 2014

Research Assistant

Used MRI and CT segmentation techniques to generate finite element models of heart, lungs, and abdominal organs, for automotive crashworthiness testing purposes

Improved mesh mating and compatibility by applying a new smoothing method to models

Education

Wayne State University

2012 - 2017

Bachelor of Science in Biomedical Engineering

GPA 3.63/4.00

Concentration in Biomechanics

Advanced coursework in musculoskeletal biomechanics, gross anatomy and physiology, and engineering mechanics

Skills

21 CFR 820.30 Design Controls: Design History File (DHF) development and documentation

Computer Aided Design (CAD): Siemens PLM NX, SolidWorks, AutoCAD

Data Processing and Programming: MATLAB, Python

Finite Element Modeling and Simulation: ANSYS, HyperMesh

Languages: English (native), Telugu (native/bilingual), Spanish (professional), Hindi (elementary)

Microsoft Office: Word, Excel, PowerPoint, Access

Mechanical Testing: Instron Bluehill and WaveMatrix

Statistical Analysis: IBM SPSS, Minitab

Tissue Modeling: Materialise MIMICS, 3D Slicer

Certifications

Engineer Intern, Indiana Professional Licensing Agency ET31700106

July 2017



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