Medical Device Engineer

Jayesh H Radadiya

****, ********* ***, ***** *****, CA-95051

******.**********@*****.*** 610-***-****

To find Graduate Biomedical/Electrical Engineering – Full time position

Objective:

Education: Master of Science in Biomedical engineering June 2014

Drexel University, Philadelphia, USA [CGPA: 3.64]

Bachelors of Engineering in Biomedical Engineering June 2011

University of Mumbai, Mumbai, India [Passed with Distinction]

Summary:

Hands on experience on electromechanical product development, circuit design and layout,

circuit test protocol, design verification plans, electrical driver development for actuators, analog

and digital circuits, Data acquisition system, signal processing, Labview, SolidWorks.

Gained experience on Xilinx PLC ladder logic design in RSLogix.

Gained experience on programmable devices including microprocessors (Intel x86, Raspberry Pi)

and microcontrollers (8051, HCS 12, Arduino).

Practical experience over firmware programming in IDE, C/C++; digital component based PCB

design and testing, EMC, I2C, RS232 protocol, CMOS technology and fabrication.

Progressive one year of experience in maintenance and operations of diagnostic and surgical

devices across ophthalmic functional areas in fast paced matrixed organization.

Researched and developed a test fixture for Laser scanning system for multimillion dollar project

on Optical Coherence Tomography, a high patient volume project.

Demonstrated experience and Knowledge of FDA quality regulations and standards like ISO

13485, ISO 14971, 21 CFR 820, 56, 50, 812, FMEA, Risk managements, Ethics & Law for

medical devices and documentation process for 510 (k), IDE, IRB and PMA for medical device.

Knowledge of Quality engineering including quality statistics, Product design, Process design,

Quality control, control charts and Six Sigma.

Experience: Drexel University/Activity of Daily Leaving LLC, PA, USA

March 2014 – Present

R&D Engineer

Designed and developed a microcontroller based Smart Cup for nutritionist professional to

measure and track the weight of nutrients inhaled by patient.

Built a microcontroller based wireless battery charger system to charge a device and utilized skills

in battery and power management.

Programed Arduino microcontroller and ADXL 335 controller to create application of

accelerometer, Gyroscope for continuous data measurement and transmission purpose.

Built hardware circuitries, developed algorithms, embedded microcontroller system, circuit

layout and design, component design using SolidWork, Prototype testing and validation.

Performed risk analyses of the electrical system using DFMEA, root cause investigation, CAPA

process to manage risk parameters and to evaluate device. Conducted Clinical Trials.

Jun 2013 – Sep 2013

Alcon-Novartis, CA, USA

R&D Engineer Intern

Researched, designed and developed Electromechanical- dynamic analysis test fixture for new

and innovative ophthalmic surgical instruments, a next-generation retina laser scanning system

and a novel 3D ophthalmic imaging device- Optical Coherence Tomography (OCT) to test and

validate the OCT-Retina laser scanning system.

Evaluated specifications, generated SPECS/requirements definition sheet, designed and

developed Data Acquisition System, Labview platform and protocol for data logging and data

analysis, 3D Printing and achieved successful completion of designated tasks before deadline.

Performed literature review, structural analysis, product characterization, ordered test parts,

technical report writing. Developed and executed test methods for SPECS verification, test set-up

liability testing and interpretation of test results, verified-validated prototype.

Exposed to high end technology available in Labs, Computer controlled systems, Complex

electro optical devices, Wet Lab experience, biology lab safety standards, stage-gate model for

product development, interacted with various departments: Quality, Regulatory board and

manufacturing facilities.

Sep 2011 – Aug 2012

My Healthskape Medicals, Mumbai, India

Biomedical Engineer

Gained hands on experience of evaluation, installation, testing and troubleshooting of devices

like ophthalmic ultrasound machine, Pantacam/Occulizer, Sterilizer, Topographer, Slit-lamps,

UVX, Microkeratome, Laser Devices.

Aided the doctor, operated and controlled the UVX and LASIK machine during surgery and

inspected the procedure with surgeon, in Corneal Collagen Crosslinking surgery & Lasik surgery.

Obtained and analyzed customer requirements through client interactions, product complaints,

observation, competitive product analysis, and current trend evaluation. Assisted marketing

group and product managers to research product needs/requirements and possible development

tactics as well as plans.

Aug 2010 – Mar 2011

Senior Design Solid State Electro Surgical Unit

Project: Mumbai University, Mumbai, India

Designed and developed a ‘Solid state Electrosurgical Unit’ used for blood less surgery with

unipolar as well as bipolar mode and working in cut, coagulation, desiccation mode.

Gained knowledge of electronics in the machine such as amplifier, inductors,

microprocessors and microcontrollers, transformers, relays, switches, board layout & design.

Designed and fabricated signal processing PCB board, performed board testing and validation.

Achieved valuable product fabrication and development experience from conception and

designing of prototype and testing. Served as team leader for project group of four member.

Awarded the Best Project during the Annual Project Display in the institute for its commendable

design, level of difficulties associated with project and innovative application.

Graduate

Projects:

Pre-Market Approval (PMA) for Implantable Cardioverter Defibrillator, Class III device

Subject: Medical Device Development, Drexel University. Mar 2013- Jun 2013

Included ISO 13485, ISO 14971, 21 CFR 820, 56, 50, 812, FMEA, Risk managements, 510(k)

Fabrication of ECG sensors and device Sep 2012-Dec 2012

Simulation of load bearing relationships between L4-L5, hip and knee joints using two

dimensional static model in Matlab Jan 2013-Mar 2013

Research Proposal on Brain Computer Interface Mar 2013-Jun 2013

Research Proposal on Low cost and Easy to use Micropump to replace syringe pump

Jan 2014-Mar 2014

Smart cup for continuous measurement of weight of nutrient drink. Mar 2014-Present

Course: Electrical Circuit Analysis and Design, Microprocessors and Microcontrollers, Analog and Digital

Electronics, Microfabrication, Medical Device Development, Medical Science, Medical

Instrumentation, Biostatistics, Programmable Devices, Biomedical Ethics and Law.

Technical Skills: C & C++, MATLAB, SolidWorks, Labview, Minitab, Eagle, PSpice, Debug, CodeWarrior,

RSLogix, Xilinx ISE, Microsoft Office Suite, MS-Project.

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