VISHWA PATEL

630-***-**** LinkedIn: www.linkedin.com/in/vishwapatel3 ac4dzg@r.postjobfree.com

SUMMARY

Biomedical Engineer with extensive experience in Imaging

Acquainted with FDA Design Control Procedures

Familiar with GCP regulations and ICH guidelines EXPERIENCE

Assistant Clinical Project Manager II, Bioclinica, Princeton, New Jersey June 2017 – Present

Assist Project manager with start-up to close-out activities for multiple phase (I-III) clinical trials with 15 to 300 sites.

Draft trial initiation documentation for communication with the sponsor as well as sites.

Prepare weekly reports with statistics on status of projects.

Assist clients with any questions/concerns with respect to project requirements specification that may occur throughout the clinical trial process.

Ensure compliance with company policies, procedures and objectives throughout the study. Summer Intern, Cedars-Sinai Medical Center, Los Angeles, California June 2016 – August 2016

● Developed an algorithm under the guidance of Dr. Debiao Li and his team to reduce the scan time for MR Imaging using methods like parallel imaging and low rank wavelet reconstruction.

● Successfully reduced scan time up to 4 times without impacting image quality. Student Intern, Icreate, Ahmedabad, India November 2014 – February 2015

● Primarily worked on disease analysis through a detailed study on pathophysiology and clinical data analysis. Studied research papers from all popular medical publications regarding coronary artery disease and prepared a detailed document about the same. EDUCATION

Masters of Engineering – Biomedical Engineering 2017 Rutgers University, New Brunswick, USA

Bachelors of Engineering – Biomedical Engineering 2015 L.D College of Engineering, Ahmedabad, India

PROJECTS

OmniHeal: A complete wound care system February 2017 – April 2017

● A smart bandage that can actively influence, monitor and react to the wound healing conditions. Created a pitch deck and executive summary for the product that included market and design considerations, FDA pathway, manufacturing and post-market considerations.

● Presented the business model to panelists from the medical device industry and received an award for the best project.

Negative Pressure Wound Therapy Device October 2016 – November 2016

Designed a low cost, portable device for wound management taking FDA regulations into consideration. Also filled a mock patent and 510(K) application for the same. Brain Tumor Detection from MR images November 2015 – December 2015

● Developed an algorithm using the watershed segmentation approach for automatically segmenting and detecting brain tumors from MR images.

● The algorithm was successfully able to segment tumors with 90% accuracy and precision. COMPUTER SKILLS

MATLAB LabVIEW Microsoft Office Suite SalesForce SolidWorks CERTIFICATES

● GCP for Clinical Trials with Investigational Drugs and Medical Devices (U.S. FDA Focus) – CITI certified

● Principles of fMRI

● Introduction to Neurohacking using R

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