Engineering Medical

Ami Shah

**** ********* ******, ***** *****, CA 95054

716-***-**** **********@*****.*** linkedin.com/in/amishah619

SUMMARY

Biomedical engineer / clinical researcher experienced in the development of clinical studies and implantable medical devices to advance medical technologies for the treatment of chronic diseases.

Clinical Research

Research and Development of Medical Devices

Verification and Validation

Neuromodulation, Electrophysiology

Statistical and Data Analysis

Human Anatomy & Physiology

Matlab, MS Excel, Tableau, C Programming

Solidworks, ISO 13485, FDA CFR 21

EXPERIENCE

Nevro Corp., Redwood City, CA May 2017- Present

Advanced Technologies Intern

Designed and developed a randomized, multi-center clinical trial to assess the safety and efficacy of modified neuromodulation parameters, that increase patient convenience and optimize device usage.

Conducted the pre-clinical verification and validation of modified firmware for Nevro’s Implantable Pulse Generator; enabling the delivery of varied stimulation programs that increase patient convenience. Generated protocols, reports and design history documentation.

Assessed and documented clinical risks and stimulation parameters to prove the safety for Nevro’s HF10 therapy for non-pain indications.

Analyzed and presented clinical evidence and data for the post-market investigation for the treatment of chronic upper limb pain.

Conducted the pre-clinical validation testing of neuromodulation system components and coordinated with manufacturing vendors to facilitate finished product. Generated protocols and engineering test reports.

Created clinical documentation for describing device configurations of implantable neuromodulation systems; facilitating surgical procedures in the operating room.

Conducted the chronic in-vitro testing of modified stimulation electrodes with impedance spectroscopy and cyclic voltammetry techniques, with the aim of reducing power consumption for electrical stimulation.

Researched the interaction of electric fields and tissues to conceptualize new technologies for the treatment of chronic diseases; potentially eliminating the side-effects of traditional treatments.

Proposed novel biological targets for electric field technologies and gained in-depth knowledge of the pathophysiology of chronic diseases.

University at Buffalo, Buffalo, NY Aug 2015 – April 2017

Researcher, Micro-Tissue Engineering and Biomechanics Lab

Design, verification and characterization of micro-tissue devices – multi-functional devices used for cancer drug screening, quantification of tissue mechanical properties and furthering the field of mechanobiology.

Spearheaded the design and development of 3D micro-tissue array devices, reducing failures by 30% and leading prototypes to the lab bench.

Collaborated with cross-functional teams of electrical, biomedical, chemical engineers and biologists to understand device design requirements and led development efforts in the laboratory.

Carried out CAD/FEA operations for micro-tissue array (drug-screening) devices by utilizing Abaqus, characterizing the biomechanical response of cells to varying external environments.

Conducted a parametric study in FEBio (Finite Elements for Biomechanics) and Abaqus (FEA) for medical devices, leading to a detailed analysis of the effect of various device designs on behavior of tissues, furthering our understanding in the field of mechanobiology.

Designed and implemented a sophisticated finite element model with Solidworks and FEA software for the proof of concept and validation of micro-fabrication of engineered blood vessels in artificial tissues, with detailed analysis and presentations.

Implemented a user-defined material subroutine in Abaqus (FEA) using Fortran and Python for the active material formulation for cellular mechanics, paving the way for the simulation of all experiments performed on the device.

Conducted feasibility studies and risk analysis using DFM principles for determining the ability of the device to function as intended for twisting tissues, leading to optimized designs and reduction of physical prototyping and testing.

Maintained detailed documentation throughout all phases of research and development and prepared a training manual for the design of medical devices for future researchers.

EDUCATION

University at Buffalo, SUNY, Buffalo, NY 2016

MS, Biomedical Engineering, 3.84 GPA

Major Project: Design and Development of Micro-Tissue Devices

Gujarat Technological University., Ahm, GJ, India 2013

BE, Mechanical Engineering, 8.5/10 CGPA

ACHIEVEMENTS

Winner, Safer Nuclear Power Plant Designs, Paper Presentation Contest, National Level Tech Symposium, GTU, India, 2013

Academic Scholarship, Gujarat Technological University, Mechanical Engineering, 2009-2013

Academic Excellence Scholarship, Vidyani Vidyalaya, 2008-2009

PROJECTS – University at Buffalo

Nanoparticles for Rheumatoid Arthritis, Fall 2014

Formulated a detailed research plan and solution to eliminate side effects associated with therapeutic treatments for rheumatoid arthritis.

Designed Thioketal Nano-capsules for a targeted drug delivery system where the drug is released only at the inflamed joint in rheumatoid arthritis, eliminating prominent side effects.

Design of a Biosensor for Cancer detection and Microchip for Immunoassays, Fall 2014

Designed a biosensor for detection of cancer biomarkers with a micro-fabricated array of micro-cantilevers, solving existing medical diagnostic problems.

Designed a microchip for performing label free immunoassays using microfluidic circuits and microcantilever arrays, with a detailed presentation of the process of microfabrication.

Finite Element Structural Analysis, Spring 2015

Carried out detailed finite element analysis and modeling for trusses, Euler and Timoshenko beams with Matlab.

Performed convergence and error analysis, torsional analysis with isoparametric formulations in Matlab.

Viscoelastic FEA for Biomechanics, Spring 2015

Developed and proposed a NIH research plan for the inclusion of the effect of focal adhesions and viscoelasticity of cells for traction force microscopy.

Proposed solutions with detailed calculations for the accurate measurement of contractile forces in cells, via improvements in the finite element analysis method for traction force microscopy.

Mechanical Optimization of Tissue Engineered Cornea, Fall 2015

Formulated a novel research plan for the tissue engineering of cornea by improving the biomechanical and tensile strength of the collagen-carbon nanotube scaffold.

Proposed the use of limbal stem cells for engineering the endothelium, thereby being advantageous for patients that suffer from both, limbal stem cell deficiency as well as corneal diseases.

Defended the proposal with the presentation of detailed literature review, research plan and future work in a team of two.

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