Medical Device

SUMMARY

*+ years of experience in Biomed space with a proven track record of designing, developing and commercializing Medical Devices

1+ years of ex-vivo and in-vitro Laboratory experience in data acquisition, data processing and analysis

Experience in R&D of medical devices and diagnostics

Hands on experience with Neurophysiology and Cardiac Electrophysiology measurements using LabVIEW and MATLAB

Experience in working on projects related to developing algorithms for biomedical image (CT, MRI, OCT) and signal processing using MATLAB

Familiarity with Quality Management System Regulations for Medical Devices - Good Manufacturing Practice Regulation, Medical Device Directive, ISO standards and FDA/EU MDR quality system regulations

Experience working on statistical methodologies, quality control and manufacturing tools, such as Minitab,ANOVA, lean manufacturing, Six Sigma, CAPA, DMAIC, FMEA etc.

Outstanding knowledge of validation and verification protocols (IQ, PQ, OQ)

Experience managing cross-functional teams spread across continents and project management

EDUCATION

Cornell University, Ithaca, NY August 2016 - May 2017

Master of Engineering in Biomedical Engineering (Medical Devices)

Sri Jayachamarajendra College of Engineering, Mysore, India September 2010 - June 2014

Bachelor of Engineering in Electronics and Instrumentation Technology

COURSE WORK

Biomedical Signal Processing Principles of Neurophysiology

Computer Vision Medical Imaging and Bioinstrumentation

Regulatory affairs (FDA) for Biomedical Engineers Biomedical Technologies for Point-Of-Care diagnostics

SKILL SET

Technical skills: C, MATLAB, LabVIEW, Minitab, Microsoft Word, Microsoft Excel, and Microsoft PowerPoint

Laboratory skills: Research, Data acquisition, Analysis, Troubleshooting, Debugging, and Technical writing

Industry skills: cGMP, ISO 13485, ISO 14971, IEC 60601, 21 CFR Part 820,510(k)S and PMA, QMS, FMEA, CAPA

RELEVANT EXPERIENCE

Research Engineer

Goldberg Lab, Cornell University July 2017 – December 2017

•Implemented Fiber Photometry imaging technique to detect brain circuits underlying motor learning

•Developed LabVIEW and MATLAB code to acquire and process bio-signals

•Conducted hardware and software interface experiments and tested system architecture

•Documented and updated risk management documentation as per EHS regulations

Graduate Student Researcher

Adie Lab, Cornell University August 2016 – May 2017

•Image-guided investigation of mechanical properties of collagen protein for early diagnosis of skin cancer using in vivo imaging modality Optical Coherence Elastography (OCE)

•Used LabVIEW software to acquire images of healthy and cancer tissues

•Designed and tested instrumentation fixtures for experiments

•Part of integration and testing for data acquisition and analysis

Software Engineer

EY (Ernst & Young) – Healthcare July 2014 – October 2015

•Trained on Agile model of software development processes for health analytics

•Generated software requirements, software design, and test documentation

•Established lean six sigma control methodologies for customer service processes

•Developed and managed quality system metrics that helped improve accuracy of QA results

Quality Engineering Intern- Medical Device manufacturing

Larsen and Toubro (L&T) - Healthcare June 2013 - August 2013

•Exposure to process verification and validation procedures (IQ, OQ, PQ) in medical device development

•Executed a risk based approach for failure analysis in manufacturing controls grounded in technical standards

•Performed standard root cause analyses on process and product development failures

•Documented FDA design control and human factors guidance standards, processes, and regulations

RELEVANT PROJECTS

Design and Development of a point-of-care hydration monitoring device

Cornell University March 2017 – May 2017

•Conceptualized design solutions and ground work for a sweat test to measure hydration levels in athletes

•Assisted in creating proof of concept (DOE, Product design enhancements)

•Documented Corrective and Preventative Actions (CAPA) that were implemented

•Facilitated FMEA, DFMEA and PFMEA on the current device

Automatic skull stripping (pre-processing) of 3D rodent brain MRI images

Cornell University November 2016 - December 2016

•Implemented morphology based pre-processing technique for segmentation of MRI images of rodent brain

•Developed an algorithm to achieve significant accuracy and computational time for processing MRI images

•Recommended software validation as per FDA design control guidance

Cardiac Patient Monitoring System

Sri Jayachamarajendra College of Engineering January 2014 – May 2014

•Designed a biomedical sensor for real time acquisition of ECG signals of a diseased heart

•Implemented algorithms in MATLAB to detect arrhythmia in cardiac patients

•Performed product testing to identify limitations and end user safety

MANAGEMENT AND ENTREPRENEURIAL EXPERIENCE

UNICEF, India January 2008

•Collaborated with a team of five for managing events in UNICEF Mysore branch

•Used marketing skills to attract sponsors to donate money towards renovating schools for children

•Raised funds up to 15000 dollars

WWF, India May 2010

•Organized rallies and competitions for fund raising events of WWF in Mysore

•Designed posters and boards for fund raising events

ACTIVITIES, LEADERSHIP AND RESPONSIBILITIES

•Active member of organizations like UNICEF, WWF, IEEE, BMES and SWE

•Guinness World Record holder for performing an Indian dance form with 3000 dancers

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