SUMMARY
• 3 year experience in Research & Development with MS Biomedical Engineering & Thesis.
• Experience in reviewing Medical device complaints and filing Medical Device Records.
• Development Experience- Risk, FMEA, GD&T, DCTM, DHF Remediation
• Knowledge of Quality management systems, QSR, ISO 13485, MATLAB.
EXPERIENCE
Zimmer Warsaw, IN
Development Engineer/ Project Lead Feb 2014-Present
• Lead and accomplished results for manufacturing transfer project held up for 2 years saving Multimillion dollars.
• Planning, coordinating and leading cross functional team ensuring that the project is in compliance with regulations.
• Ensuring product prints are updated as per specifications (GD&T) and creating Engineering Change Notice.
• Remediation- Performing post market review of designs and prints, creating change notice, reviewing DHF.
• Remediation- Performing risk analysis and creating Design FMEAs for post market products.
St Jude Medical Sunnyvale, CA
Product Surveillance Coordinator- Remediation project August 2013- December 2013
• Review and Investigate Medical Device complaints.
• Prepare Medical Device Records (MDRs) as per to the U. S. Food & Drug Administration (FDA), CFR-21 part 803/820
• Coordinate the resolution of complaints and maintain quality documents to ensure Regulatory compliance.
Optical Imaging Laboratory-UTA Arlington, TX
Graduate Research Assistant- Thesis Project May 2011–Dec 2012
• Estimate the recovery state of children affected by Cerebral palsy by quantifying the motion metrics.
• Designed and aligned the Infrared cameras setup.
• Formulated and calibrated the system along with implementing experiments to estimate errors of the system.
• Estimated 3D motion data by developing algorithms using Computer Vision Robotics.
• Implemented designed system at Motion Laboratory, Texas Scottish Rite hospital.
• Statistically analyzed the data of hand motion coordination in Cerebral palsy patients.
Wockhardt Hospitals LTD Mumbai, India
A Joint Commission International Accredited hospital affiliated with Harvard Medical School
Biomedical Technician ( Internship) July-December 2009
• Resolved technical issues including testing and maintenance of electromechanical equipment in the hospital.
• Performed calibration, component level and mechanical testing of electronic circuits of injection systems.
PROJECTS AND CERTIFICATIONS
EOG based Remote Control, UTA, TX Fall, 2010
• Presented a poster for operating remote control with si...
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