Product development, Regulatory Affairs, Quality Management

TEJAL BHAGWAT

****-** ******** ****** *** ***

Philadelphia PA 19104

Contact No.: 801-***-**** E-mail: *****.*.*******@******.***

OBJECTIVE

Seeking a full-time position in medical device industry from December 2012 to enhance my technical acumen and gain experience in device development to meet newer challenges in medical engineering.

EDUCATION

M.S. Biomedical Engineering Expected: December 2012

Drexel University, Philadelphia

B.E. Biomedical Engineering May 2010

Vidyalankar Institute of Technology, University Of Mumbai, India

WORK EXPERIENCE

Design & Development Engineering Intern, Engineering Department

InspiRx Inc, New Jersey, September 2011- Present.

Quality Management:

• Expanded InspiRx Inc’ Quality Management System (QMS).

• Worked extensively on the risk management system for assigned projects. This included drafting risk management plan for assigned projects, expanding the risk analysis matrix; process FMEA, and creating risk analysis summary report documents according to ISO 14971: 2007.

• Assisted in the required documentation for the 510(k) application of a respiratory product.

• Drafted and implemented various management plans, test protocols and procedures, work instructions, and technical reports related to assigned projects.

• Lead creation and maintenance of inventory sheet for samples used for Engineering/R&D.

Product Design and Development:

• Contributed in various brainstorming sessions for two different projects in the concept phase.

• Designed and modified initial device design in Pro-Engineer at the design feasibility stage.

• Designed and performed various hands-on testing for design verification and test method development. (Design of Experiment)

Research Assistant, Orthopedics & Biomechanics Lab

Drexel University, November 2010- September 2011.

• Generated 3D reconstructions from CT scans of pediatric thoracic cage using Analyze 8.1.

• Calculated various geometric parameters of the thoracic cage using MATLAB.

• Quantified, analyzed and compared human thoracic geometries with Anthropomorphic Test Devices using Pro-Engineer.

Intern, Service Department

Maquet Medical India Pvt. Ltd, Mumbai, India, June 2009- December 2009.

• Handled service and installation of MAQUET ventilators and GETINGE sterilizers.

PROJECT AND RESEARCH WORK

Wheelchair for Quadriplegics (Sip and Puff Mechanism) – 510(k) Premarket notification

School of Biomedical Engineering, Drexel University, January 2011.

• Conceptualized the application of sip and puff mechanism for the product and reviewed the existing patents, articles to ascertain the novelty of the concept.

• Drafted dummy FDA 510(k) summary as a final deliverable of a group project.

Pneumatic Lithotripter -Invasive Kidney Stone Breaking Instrument

Vidyalankar Institute of Technology, University of Mumbai, January 2009 – April 2010

• Designed basic block diagram for pneumatic lithotripter.

• Developed a working prototype: Programmed the Intel 8051 micro-controller.

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