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Quality Control Engineer

Location:
Wayne, NJ, 07470
Posted:
October 16, 2017

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Resume:

MOURYA BOMMIREDDY VENKATA SUNDARA

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

Wayne, New Jersey, 07470

609-***-**** ac2sjk@r.postjobfree.com

NEW JERSEY INSTITUTE OF TECHNOLOGY, NEWARK, NJ May, 2016

Candidate for Master of Science Degree in Biomedical Engineering

Relevant courses: Computational Biomechanics, Bio-robotics, Biomedical Implant design using CREO CAD software, Human Gait Analysis, Project Management, Quality control and FDA regulatory affairs, SAS programming for Biostatistics, Medical device development

BIRLA INSTITUTE OF TECHNOLOGY AND SCIENCE, PILANI, INDIA June, 2014

Candidate for Master of Science Degree in Biological sciences and Bachelor of engineering in Chemical Engineering

Relevant Courses: Biophysics, Chemical Engineering Thermodynamics, Mass and Heat transfer, Fluid Flow Operations, Tissue engineering

Biomedical Engineer with hands on experience in Bio-statistical data analysis, Biomedical implant design, Process control, Quality control and Human gait analysis, BSI certified Lead auditor for ISO 13485, SAP (QM) I am actively looking for jobs in the healthcare industry which can challenge me and provide the right platform for long term growth.

WORK EXPERIENCE

MEDIN TECHNOLOGIES, 11 Jackson Road, Totowa, NJ. Quality Engineer

Sep 2016 - Present

Conduct analyses of in-process materials, raw materials, environmental samples, finished goods, Calibrate, validate, or maintain laboratory equipment. Use of Comparator for accurate measurements when needed, Conduct internal assessments and audits as required and produce detailed report of the findings, Perform visual inspections of finished products, Serve as a technical liaison between quality control and other departments, vendors, or contractors Train operators to perform procedures while maintaining quality in accordance with ISO 13485 regulations, Interpret test results, compare them to established specifications and control limits, and make recommendations on appropriateness of data for release, Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, or protocols, Write standard operating procedures and work instructions for quality control activities, Perform validations or transfers of analytical methods, Supply quality control data necessary for regulatory submissions, Write technical reports or documentation such as deviation reports, testing protocols, and trend analyses, Develop and qualify new testing methods, Evaluate new technologies and methods to make recommendations regarding their use, Performed inspection in all departments including receiving inspection, shipping, assembly, in – process inspection . Knowledge of inspection techniques, measurement devices, calibration of devices and dimensional tolerance

Perform engineering change control, statistical process control and IQ validation protocols, Performed Fabri-vision machine programming, validation of new and existing equipment, Performing risk assessment on process and parts, Conduct root-cause analysis( 5 Y method, fish bone diagram analysis etc.), Maintain FDA Quality System Requirements/ISO 13485, Process Return Material Authorization for customer returned parts and find root cause . Open up a Rework order with the process map necessary to obtain desired outcome, Identify areas of improvement needed, create and resolve CAPA's, Perform Root cause analysis of defects

STRYKER CORPORATION, Mahwah, NJ & NEW JERSEY INSTITUTE OF TECHNOLOGY, Jan 2016 - Aug 2016

University collaboration Project

Conducted HIP DISLOCATION ANALYSIS - Improving range of motion of hip implant using motion tracking software successfully created an experimental protocol for quantitatively measuring Activities leading to Hip Dislocation, Strain analysis of human brain under frontal impact, Design of knee implant & human exoskeleton for knee injuries using core 3.0

CENTRAL LEATHER RESEARCH INSTITUTE, Chennai, India. Research Analyst Intern June 2013 – June 2014

Developed a predictive algorithm to predict the growth of the fungus Aspergillus tamari, Predicted the growth of The fungus at various intervals of time, Performed Regression analysis and Implemented Machine learning algorithms using Support Vector Machines, Developed a controller for producing desired amounts of the fungus at desired times.

ROURKELA STEEL PLANT, Orissa, India Quality Engineer intern June 2012 - Sep 2012

Implemented Quality control Techniques to minimize loss of Raw material in the cold rolling mills at Rourkela Steel Plant, Studied the process of Cold rolling and worked on Implementing Changes aimed at efficiency and safety

Improved safety measures by designing new safety protocol Procedures, Developed a comprehensive report on the various activities performed at the Rourkela steel plant.

TECHNICAL PROJECTS

HIP DISLOCATION ANALYSIS - IMPROVING RANGE OF MOTION - Stryker Corporation & NJIT

Researched upon activities of daily living leading to hip dislocation post total hip surgery, Developed a Protocol for recreating the identified ACTIVITIES OF DAILY LIVING in the GAIT LAB at NJIT, Newark, Worked extensively on Motion capture software OPTITRACK to capture data, Recorded the Joint angles, Flexion angles, Abduction and Adduction angles and internal rotation angles corresponding to the performed activities, Captured Data submitted to Stryker Corporation, Mahwah, NJ and fed to Stryker’s Range of Motion Predicting software to increase the accuracy of the same and thus help Stryker develop Hip Implants with a wider range of Motion.

STRESS – STRAIN ANALYSIS OF HUMAN BRAIN UNDER FRONTAL IMPACT

Formed 3-D image of the brain using 2-D FMRI images using the Mimics software, simulated a frontal impact on the head using ANSYS Simulation software, formed a time dependent model of the human head under frontal impact

CAD DESIGN OF TOTAL KNEE IMPLANT & HUMAN EXOSKELETON FOR KNEE INJURIES USING CREO 3.0

Researched upon the various human exoskeletons in the market, Developed a novel design of a Total knee Implant using CREO 3.0, Designed own novel version of human exoskeleton for assisting patients with knee injuries, Over 200 hours of work put into developing each CAD model.

LEADERSHIP QUALITIES

PRESIDENT, Graduate Biomedical Engineering Society, NJIT January 2016 – May 2016

DEPARTMENT REPRESENTATIVE –Biomedical Engineering Department, NJIT Sept 2015 – May 2016

Built a Team of students to work for the cause of making GBMES an active club at NJIT, Initiated GBMES INDUSTRY TALKS to bring in more industry involvement at NJIT – Invited Werum IT solutions, Improved NJIT’s Visibility and Ranking – was part of the student association which hosted cultural and Technical events (http://colleges.usnews.rankingsandreviews.com/best-colleges/njit-2621).



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