Summary





2 years of challenging work experience involving medical devices, engineering, procurement and project management of national level health sector projects.
2+ years of progressive research experience in software development, instrumentation, troubleshooting of data logging devices and active participation in experiments involving spinal injured subjects.
Experience in FDA regulatory affairs, 510 K submissions, ISO 13485, Risk analysis and management, Design of experiments DOE, 6 Sigma, FMEAs and CAPA.
Strong hold on fundamentals of IQ, OQ, PQ, Product development life cycle, Sterilization and packaging standards, Patents, Intellectual property rights IPR related aspects of medical devices.
experience in programming using MATLAB, LABVIEW and PRO-E for extensive applications in signal processing and rehabilitation engineering.
Accustomed to an environment where commitment and deadlines are a priority.
Young energetic quick learner with excellent analytical, interpersonal and organizational skills.


Achievements

University of Miami Departmental Scholarship for the year 2007 for outstanding academic performance
Biomedical Instrumentation Center Gold Medal for the year 2005 and best outgoing student of the year 2005 for the outstanding academic performance in Biomedical Engineering .
Certificate of experience course in German Language from CIEFL Center for English and Foreign Languages , Hyderabad .
Successfully completed distance learning course on Intellectual property rights from WIPO World Intellectual Property Organization .
Severed as Volunteer , Organizer and Co-Conveyor for the national level technical symposium MEDITECH
Served as the Executive member for promoting the college cultural festival ALLGORHYTHMS-2005 and college magazine .
CHAITHANYA K MUMMIDISETTY
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Employment

May, 2008 -  August, 2008
Quality Engineer Internship

Updated Design FMEAs with failures and potential root causes of various endo-surgical devices based on their field performance.

Coordinated with teams at different Boston Scientific facilities in monitoring the status of CAPAs initiated on device designs and their testing.
Acquired thorough knowledge of the standard operating procedures SOPs and protocols for quality management.
Real time aging studies of device packing, data consolidation and documentation.
Statistical analysis using MINITAB of the data obtained from testing the package integrity and sterility.
Packing and logistics management of devices in transferring to testing sites and warehouses.

Gained hands-on experience in maintaining documents as per QSR of FDA.

July, 2005 -  December, 2006
Biomedical Engineer

Setting required ISO standards and specifications of equipments and instruments that are to be supplied to various hospitals across India.
Assessed the feasibility of project in terms of budget requirements and timeline for various healthcare projects funded by the World Bank and Government of India.

Participated in discussions with technocrats of both the ministry of health and family welfare and various healthcare organizations in improving healthcare standards for AIIMS and other apex institutions in India.

completed USD 20 million worth project in record time of 2 months for National AIDS control organization resulted in USD 200000 savings and approval for next phase of project to the organization.
Prepared tender documents as per standard World Bank guidelines Red Book and evaluated tenders for their technical compliance of the offers.
Organized tendering processes which includes advertising in national newspapers and bid opening
Handled meetings with IPC Integrated Purchase Committee of Ministry of Health and Family Welfare, Govt. of India.
Inspected and tested the equipments for required ISO and CE standards during the pre-dispatch and installation.
Monitored supplies and logistics of various equipments and Drugs across the country.
Efficiently handled emergency procurements of equipments and medical relief aid during natural calamities, earned appreciation from the office of Prime minister of India.

Other duties involve issuing dispatch clearances to technically fit supplies and bill processing.

December, 2004 -  May, 2005

Project title : Neural Networks based Cardiac disease identification
Coordinated with various hospital authorities for assistance in ECG data collection and analysis.
Participated in discussions with physicians to identify the potential features in ECG to classify cardiac diseases.
Determined the weightage for nodes of neural network and collaborated in developing the algorithm.

Research Assistant The Miami Project to cure paralysis

May, 2007 -  Present

Experienced in building and troubleshooting dedicated circuits for processing and recording EMG signals.
Active participation in experiments for recording long term 24hr EMG signals from spinal cord injured subjects.
Software development and maintenance for data acquisition and analysis.
Developed visual tools by integrating MATLAB and Dadisp for manual analysis of spasms.
Developed new method to analyze clonus a type of spasm using software routines developed in MATLAB as part of Master s thesis.
Participating in Journal Club meetings to discuss new updates and plan for new experiments.

Making market search, obtain quotations and ordering new supplies for Lab activities.

January, 2007 -  August, 2007
Graduate Assistant

ARCH Pilot Project - Leachability and harmful effect of arsenic, chromium and copper associated with CCA - treated wood
Designed the experimental setup and labeling methods for sample collection, incubation and storage.

Performed HPC bacteria tests on the processed samples, organized the analysis results and documented for publications.
Planning and routine maintenance of experimental setup.

Participated in review meetings to collaborate with other research teams at FIU and RASMAS to discuss and plan experiments.

May, 2003 -  March, 2004
Student Assistant

Project title - Measurement of Endothelial Dysfunction using a temperature sensor
Identified the properties of the endothelial cells and their response incase of cardiac disorders.
Studied characteristics of different temperature sensors transistors and identified the suitable 1 for experimental needs.
Prepared layout and built circuit for temperature monitoring.

Education

Skills

Operating Systems MS DOS, Windows 95/98, XP. Programming Languages C, C++ and Java. Software Packages Easy PC, ORCAD, Zoom, MATLAB, Minitab, SPSS, LABVIEW, PRO-Engineer. Microprocessors Intel 8085, Rabit Microprocessor 3000 series, Tattletel8. Applications Office Word, Excel, Power point, Access.
Data collection, analysis and documentation of results for conferences and publications. ACADEMIC PROJECTS and PUBLICATIONS : Master s thesis title Analysis of EMG during clonus using Wavelets, College of Engineering, University of Miami, Florida. Presented paper on Measurement of Endothelial Dysfunction using a temperature sensor. During a seminar at Biomedical Engineering Dept, Osmania University. Published a paper on Vagal Nerve Stimulation Techniques at MEDITEDH - 2004 a national level technical symposium. Analog Interfacing of ECG and Respiratory Signals for Central Monitoring System Tools/Language used : RCM 3100 Rabit Core Module Processor, Wi - Fi. or Dynamic C