Regulatory Affairs • Quality Assurance • Validation Engineer

VIJEY KUMAR KANNIAPPAN BAKTHAVACHALAM

*** **** **** ****** • Los Angeles, California, 90007

213-***-**** • *****.***@*****.***

BIOMEDICAL ENGINEER

Regulatory Affairs • Quality Assurance •Software and Hardware Development • Research & Development

EDUCATION

Master of Science in Biomedical Engineering (Spring 2011)

University of Southern California, Los Angeles, California

Bachelor of Technology in Biomedical Engineering

Sathyabama University, Chennai, Tamil Nadu, India

PROFESSIONAL EXPERIENCE

GIVEN IMAGING, SIERRA SCIENTIFIC INSTRUMENTS, Los Angeles, California • 2011-Present

An Imaging company specializing in pH Monitoring, Pressure sensing and catheter production for wide range of application.

• Engineering Intern, Software and Hardware Development: Design, Develop and Test Hardware, Software and drivers. Prepare Requirement Documentation, Test Plan, Test Procedures and Validation Procedure. Preparing Various Documents for regulatory (FDA) submission

CHILDREN’S HOSPITAL RADIOLOGY DEPARTMENT, Los Angeles, California • 2010-Present

The largest hospital in Southern California dedicated to diagnosing and treating children. (work at weekends)

• Research Assistant, Image Processing Lab: Remove extraneous information from MRI images through skull striping, Linear Registration and Non –Linear registration processes for image Processing. Analyze images in search of a target element and the level of concentration in the brain.

CENTRAL GOVERNMENT HEALTH SCHEME, Chennai, India • 2008-2009

Indian government program providing health services to government employees and retirees.

• Research Assistant for the Chief Medical Officer: Assisted in several biomedical research projects conducted by Dr. P.S. Suresh, MB, BS, DMRD. Examined variations in optical and surface transducer functionality. Researched and measured dangers posed by radiation from diagnostic equipment. Analyzed the potential of near infrared radiation as a noninvasive imaging source.

BARNARD INSTITUTE OF RADIOLOGY, Chennai, India • 2006

Government-run general hospital.

• Intern: Maintained diagnostic imaging equipment including X-ray, CT and MRI machines, diagnosing problems, dismantling and reassembling machinery, and calibration.

CORE COMPETENCIES

Strategic Analysis • Risk Management • Quality System/ Standards/ Audits • Global Regulatory Compliance Biomedical Research & Development • Signals & System Analysis • BioMEMS & Nanotechnology • Image Processing • Radiology • Equipment Troubleshooting/ Repair • Information Technology • Computer Programming Audits • Database Analysis • Teamwork • Collaboration • Problem Solving • Scientific Papers/ Presentation

TECHNICAL SKILLS

BIOMEDICAL REGULATIONS: 21 CFR 801 • 21CFR 803• 21CFR 814 • 21CRF 820 • 21CFR 822 • 21CFR 860 • ISO 13485:2003 • ISO 14971 • GMP • GCP • GLP • EU - MEDDEV • GHTF

COMPUTER SKILLS: MATLAB • Brain Suite 09 • C • C++ • Java • SQL • FSL • FreeSurfer • Visual Basic • MS DOS • CAD • Windows - XP / Vista / 7 • Microsoft Office Package

RESEARCH PROJECT HIGHLIGHTS

• Structure and Management of Clinical Trial (2011): Preparing Site Qualification Procedures protocol and other procedures, forms and documents for conducting Clinical Trial.

• International Approach to Medical Product Regulation (2010): Developing a strategy in order to market a drug (Combinational Product) in European Market and Japan.

• Novel Diagnostic Point of Care Platforms for Bio Terrorism Biological Agents (2010): Developing a theoretical approach to detect airborne biological agents using BioMEMS and nanotechnology.

• Quality Audit Report (2010): Developing a pre-audit checklist, auditing necessary documents and preparing an audit report.

• Quality Assurance (2010): Preparing documents such as work orders, traveler and manufacturing standard operating procedures, spec sheets, design summaries and finished product spec sheets.

• Ultrasound Resolution (2010): Designing and analyzing the effect of filtering on axial resolution by changing filter bandwidth and moving center frequency.

• Sequence Learning in a Simplified Cerebellum-like Model (2009): Developing a MATLAB program to simulate storing and retrieving data from brain cells.

• 501(k) Clearance Project (2009): Preparing a mock document for 510(k) clearance from the FDA for a knee prosthetic, including device and technical specifications and manufacturing methods.

• Hodgkin-Huxley Model of the Action Potential (2009): Developing a MATLAB-based computer program simulating Na+ and K+ channels and generating action potential.

• Theoretical Method for Correlating Electroencephalography / Near Infrared Spectroscopy to Identify Activated Brain Regions at the Onset of Seizure in Epilepsy (2007-2008): Conducted at the government hospital, Chennai.

PROFESSIONAL DEVELOPMENT

Java Programming Language Certification • Diploma in Information Technology•

Repair, Maintenance and Calibration of Biomedical Equipment

AFFILIATIONS

Associated Students of Biomedical Engineering

Key achievements:

• Chosen as 1 of 30 participations nationwide for advanced training by the Central Scientific Instruments Organization for the Biomedical Technology-Based Entrepreneurship Development Program (2009).

• Selected among best student engineering projects in India and featured in the Technovation ’08 exhibition in Chennai for an Optical Brain Imaging project (2008).

• Presented multiple papers at major industry events, including the International Conference on Applied Bioengineering at Sathyambama University in Chennai (Spatial and Temporal Analysis of Frontal Lobe Epilepsy, 2007), and Convergence 2K7, a national technical symposium on biomedical instrumentation, at the VNR Vignana Jyothi Institute of Engineering and Technology in Hyderabad, India (Vision and Corpuscallosum, 2007).

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