Engineer Medical

UJWAL PARIKH

Email: ******.*****@*****.*** . Phone: 503-***-****

EDUCATION New Jersey Institute of Technology, Newark, NJ

CPGA: 3.87

M.S Biomedical Engineering

University of Mumbai, Mumbai, India

Grade: Distinction

B.E. Biomedical Engineering

RELEVANT Medical Device Computational Biomechanics Bio MEMS Orthopedic Medical

COURSES Design Device

Intro to Advanced Design of Biostatis Cardiovascular

Neuromuscular Orthopedic Implants tics Mechanics

Engineering

AREA OF Product Development and Design CAD Design and analysis

EXPERTISE

Regulatory Design of Micro Devices

WORK Vision Medical Systems, Mumbai, India

EXPERIENCE June '08- June '09

Field Service Engineer

Performed planned maintenance and escalated break/fix on ultrasound

imaging systems manufactured by GE Healthcare Pvt. Ltd. specialized in 2D,

3D and Color Doppler imaging.

Complete Preventative Maintenance and performed appropriate testing in

compliance with the SOPs (Standard Operating Procedures) to confirm that

system operates according to manufacturer's specifications.

Assisted product development team with design of prototype and provided

testing & validation support whenever required.

Acted as a liaison between production staff and customer base to improve

the functionality of the system.

Breach Candy Hospital Trust, Mumbai, India

July '07- Nov '07

Biomedical Intern

Troubleshooting, servicing, calibration and preventive maintenance of

medical equipments, general electronic & telecommunication like Patient

monitors, EKG machine, ventilators, X-ray machine, Infusion pumps.

Assisted the Bioengineering department in maintaining proper documentation

for the sales and purchase of new medical equipments.

Evaluated and executed changes for the annual contract documents of

existing medical devices

MASTER'S Measurement of the penetration depth of near infrared radiation in neural

THESIS tissue In vivo Fall 2011

The transmittance curve was plotted for different penetration depths at

NIR wavelength and the scattering coefficient for rat brain gray matter

was determined using Monte Carlo simulations.

PROJECT Regulatory Affairs Manager

Spring 2011

As a class project was responsible for preparing the Premarket

Notification, PMA, IDE as per 21 CFR, RFD and regulatory rationale for a

virtual rhBMP manufacturing company.

Developed the regulatory pathway by deciding the device class, claims,

governing agency, different testing protocols using the ISO 10993

standards and supervised compliance with the act for Registration and

listing as per 21 CFR Part 807, Labeling as per 21CFR Part 801, GMPs set

forth by quality as per 21CFR Part 820, and electronic product radiation

control provisions as per 21 CFR 1000-1050 for US FDA approval.

Collaborated with clinical research, quality, Marketing, Legal, Medical

Affairs, Managed Care, and advertising agencies and marketing team giving

them inputs in preparing clinical protocols, risk analysis, Design Input

Document (DID), Design History File (DHF), Gant Chart and Design

development process.

Design, FEA and FMEA of Hip, Knee and Spinal implants

Fall 2010

Modeling and design of Total Hip Replacement & Resurfacing systems, Total

Knee Replacement systems and spinal implants using ProE 5.0

Tested the implant designs for compliance with engineering principles, FDA

regulations like ISO 13485 and FDA 21CFR 820, industry requirements,

safety standards and related specifications based on the commercially

available implants.

Mechanical properties of materials, including wear and failure modes

(FMEA) associated with typical implants.

Kinematics and surgical protocols of implants.

FEA analysis of implants using Pro Mechanica and studied large

deformations, fatigue, optimization, review and analysis of results.

Bone Fractures and Metal Plates

Spring 2011

Static Finite Element Analysis (FEA) on different types of loads causing

bone fractures using Ansys 11.0

GUI and code based static, harmonic and modal failure mode analysis (FMEA)

for different materials of metal plates using Ansys 11.0.

Electromyograph Acquisition and Analysis

Spring 2008

Successfully designed & assembled components and developed a circuit for a

voluntarily generated EMG machine which recorded the signal using 16-bit

AD converter and interfaced it to a PC through the RS-232 port.

Review of Neuroprosthetic Electrical Stimulation

Fall 2009

An article review of neuroprosthetic effect of implanted functional

electrical stimulation (FES) system to facilitate motor and sensory

incomplete spinal cord injury.

PROFESSIONA Member of Institute of Electrical and Electronics Engineers (IEEE) -

L 2005-2006

ORGANIZATIO Engineering in Medicine and Biology Society (EMBS)

N

COMPUTER Pro- Engineer 5.0, Ansys 11.0, C, C++, Java J2SE 1.5, HTML, PSPICE, MATLAB

SKILLS 7, Microsoft Office, Pro-Mechanica, Adobe Photoshop CS

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