Project Manager Engineer

Asha Aravindakshan Pulikkal

**-** ******** ****** *** #3R E-mail:**********@*****.***

Harrison, NJ 07029 Contact: 551-***-****

OBJECTIVE:

Self-motivated and enthusiastic Biomedical Engineer with a Master’s degree seeking a Full Time Industrial opportunity in Research and Development in a reputed Healthcare organization.

ACADEMIC ACHIEVEMENTS:

New Jersey Institute of Technology (NJIT), Newark, NJ

MS Biomedical Engineering Graduated May 2011

Nirma University, Ahmedabad, India

B.Tech Instrumentation and Control Engineering June 2009

RELATED EXPERIENCE:

New Jersey Institute of Technology, NJ

Sept 2010 -Dec 2010

Project Manager (EM 636)

-Software Development Life Cycle (SDLC) experience by developing project plans and directing project resources

-Monitored and managed the project schedule and planed each milestone

-Performed RISK management and resolved issues arising during the project life cycle

-Documenting and organizing project meetings

Inmed Equipment Pvt. Limited, Baroda, India

July 2008-June 2009

Manufacturer and exporter of Medical / Hospital / Surgical equipment

Assistant Engineer Trainee

-Highly selective Pre-employment training designed to reinforce the necessary technical skills

-Worked with Defibrillators, Oxygen Analyzers, Nerve locators/stimulators, Electrosurgical units, Respiratory care systems and Incubators

-Hands on experience in diagnostics instrumentation : construction and maintenance, safety evaluation, efficiency testing

-QR/QC experience in product development

1.ISO 13485:2003 – Quality Management Systems – Requirements for Regulatory Purposes

2.ISO 14971:2007– Application of risk management to medical devices

3.ISO 9000:2005– Fundamentals of Quality Management Systems

4.ISO 10993– Biological evaluation of medical devices

5.FDA Regulations in Medical Devices– 21 CFR Part 820.30:Quality System Regulation, PMA, 510(k)

6.cGMP knowledge

New Jersey Institute of Technology, Newark, NJ

May 2010-Aug 2010

Academic Computing Services

PC Lab Assistant

-Monitor and maintain laboratories

-Helped students to create and maintain accounts and system log in

-Printer, Scanner and Peripherals maintenance and configuration

-Data management and Technical support

-Troubleshooting and Team work

PROJECTS:

Total Joint Replacement System

-Developed a Total Knee and Hip Replacement System CAD design

-Designed the surgical protocol with detailed specification analysis: Distal bone design, Generic femoral components.

-Performed FEA Analysis of Femoral component and Evaluation of result - FEA output files and reporting

-Failure modes and Effect analysis were performed

ASL (American Sign Language) Analyzer

-Study and analysis of various sign languages and comparison to the ASL

-Developed a software to display and analyze the alphabetical and numerical combinations using VRML /Simulink interface in MATLAB

-Designed two operating modes: Manual and Automatic

-Manual mode with external input/user input option and Automatic mode displaying and analyzing pre-set combinations

Pre–Clinical Animal Protocol

-Prepared Design Input Document for Clinical Protocol of PCL- HA/TCP composite scaffold

-Worked on Myrtle Rabbit Pre-clinical Protocol

-Experience in GLP (Good Laboratory Practices)

-Knowledge on ISO 10993-1 to 18 on Evaluation of Biocompatibility of material prior to clinical studies, ADME (Pharmacokinetics) Testing and ICH Guidelines

EMG Moving Averager

-Patient data collection and analysis of EMG Signal

-Designed a software on MATLAB to filter the noise using filter combinations from the source to sink

-Studied and evaluated various electrodes and their effects on noise reduction in signal transmission

Analysis of fMRI signal relating to signal dependency due to neurological disorders

-Studied fMRI data of over 1200 patients worldwide

-Designed a MATLAB program for post-processing the raw fMRI data to find Hurst exponent

-Analyzed the Hurst Exponent of different brain regions to find functional irregularities in brain activities on the based on patient classes

Oxygen Analyzer

-Used Inmed Oxygen analyzer IN-O2 for continuous monitoring of oxygen concentration in Anesthesia machines and measure the oxygen concentration in gas mixtures

-Monitored Medical Oxygen supplied by delivery equipment

-This equipment is a small, portable battery as well as mains operated Microprocessor controlled unit with high sensor life having fast response time and a LCD display

TECHNICAL SKILLS:

Design Tools:: Auto CAD, Pro E, Lab View (Basics), Virtual Reality Modeling Language (VRML)

Management Tools:: Microsoft Project, MS Office Suite

Mathematical/Statistical Tools:: Statistical Analysis Software (SAS)

Assembly Level Languages:: OMRON PLC, Circuit Maker, Microprocessor and Microcontroller

Operating Systems:: Windows OS, Vista, Mac OSX

Languages:: MATLAB, Simulink

EXTRA- CURRICULAR ACTIVITIES:

-Graduate Student Association (GSA) Representative, Biomedical Engineering (NJIT)

-Graduate Biomedical Engineering Society (GBMES) Secretary

-Indian Graduation Student Association (IGSA) Treasurer

-Worked with NGO organization Hyacinth

-Volunteered the Research Day conducted by Graduate Student association

-Worked with Student Issue Committee and Awards Committee, Graduate Student Association (GSA)

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