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BioMedical engineer, Quality Engineer, Lean Six Sigma specialist

Arlington, Texas, 76013, United States
April 16, 2018

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Neha Jain

Biomedical Engineer Product Development Quality Control & Testing Certified LEAN Six Sigma- Green Belt FDA & ISO CAPA 817-***-**** Texas, 76013

• Medical Device Design & Implementation: Improved ECG device performance for better signal acquisition using the PAN Tompkins algorithm at the University of Mumbai.

• Quality Engineering: Applied FDA and ISO standards like 21 CFR 820 and ISO 13485 to maintain product quality.

• Product Testing and Analysis: Performed test planning and execution and result reporting for controlled wound healing and successful tissue regeneration devices as part of BIODOME pre-market approval process at the UT Arlington Research Institute.

• Skills: Cell and Tissue Culture, Cell Histology, Chromatography (HPLC), 3D Printing, Molding Techniques, Image Processing. Engineering & Research Experience

Research Assistant – UT Arlington Research Institute 9/17-Present Aided in research and development of cutting-edge therapeutic medical devices. Key Projects include:

• REHEAL Glove Project: Ensured cost-effective manufacturing while maintaining product quality by analyzing existing processes. Redesigned the elementary framework.

• DIABETIC Foot Insole Project: Conducted successful device tests for pre-market approval. Research Assistant – UT Arlington, Arlington, Texas 10/16 – 8/17

• Participated in cardiovascular wound healing research projects in Dr. Kytai Nguyen’s lab - drug delivery & Nanomedicine program.

• Supported endothelium regeneration following a cardiac arrest by developing EPC-capturing drug loaded nanoparticles that targeted injured blood vessels.

• Investigated drug release mechanisms from nanoparticles using protein assays. Performed particle characterization, degradation, stability, cytotoxicity & platelet adhesion, immunohistochemistry, and other studies using blood and tumor tissues.

• Designed experiments to achieve planned research goals. Followed detailed operating procedures and protocols with minimal supervision in a lab environment. Wrote three scientific papers for the American Heart Association funded projects. Research Assistant (Patient Monitoring Devices) - University of Mumbai 6/15 – 12/15 Biomedical Engineer, Fortis Hospitals 8/13 – 7/14

• Maintained, calibrated, and troubleshoot critical care equipment in the ICU/ICCU and blood chemistry labs.

• Trained 200 end users such as doctors, lab technicians, and nurses on accurate functioning and application of advanced medical equipment. Installed machines like CT, 3D color Doppler, and ECMO. Engineering Projects

Development of Quality Check Standards for ECG Device using Six Sigma Elements: Identified and implemented critical experimental design parameters using VOC, AHP, SIPOC model, DOE, Statistical Process Control, and FMEA. Proposed, developed, and managed complete clinical development program for a Class II device. Achieved 510(k) & 21CFR 820. 3D Printing and Designing of Scaffold for Cartilage Regeneration: Designed & 3D printed a prototype scaffold for cartilage regeneration using Solidworks. Led prototype fabrication and incorporation. Study of Effect of Combination of Two Different Growth Factors onto BMScs to induce Chondrogenesis: Determined growth factor properties and effects of TGFβ-1 and BMP-2 on cells for chondrogenesis. Use of Nanobots to Deliver Drug for Treating Breast Cancer: Designed a nanoparticle made up of pNIPAAm that contained multiple DNA nanobots. Achieved targeted drug delivery by using an external magnetic field. Education

MS Biomedical Engineering at University of Texas at Arlington GPA 3.3 2018 BS Biomedical Engineering at University of Mumbai GPA 3.7 2016 Programming Tools & Applications: R, Java, C/C++, MATLAB, LabVIEW, Keil, ImageJ, Solidworks, Simulink Modelling, NEURON, Proteus.

• Performed analysis of the algorithm, planning and development of the prototype

• Successfully designed and implemented delivery of the prototype project

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