Engineer Medical

SUMMARY:

. More than * years of experience in areas of quality assurance,

manufacturing and clinical engineering

. Knowledge of FDA design control guidelines, 510(K) Pre-market

notifications, IDE submissions

. Strong knowledge of FDA 21CFR part 820, ISO 13485, ISO 14971, EU medical

device directives.

. Excellent experience in engineering fundamentals, project management and

medical device technology

. Formally trained on CAPA, FMEA and ISO13485 auditing at Central

Connecticut State University

. Understanding of engineering tools like Six Sigma, Design of Experiment

and statistical process control

. Extensive knowledge of human physiology, surgical procedures and

operating room environment

. Some experience with statistical software Minitab and design engineering

tools Pro-E, MATLAB

. Self-motivated, organized, proficient team player with excellent

communication and interpersonal skills

PROFESSIONAL EXPERIENCE:

. Biomedical Engineer

Soma Technology, Inc. Connecticut

(Mar 2007 till Present)

. Successfully improved processes, quality of finished products as a

quality and manufacturing engineer

. Implement CAPA procedures\root cause failure analysis for medical devices

investigating customer complaints and device non-conformities.

. Document CAPA, train departments/engineers on CAPA investigation results

to improve processes

. Develop test methods, validation protocols and implement procedures to

ascertain remanufactured medical devices conform to OEM specifications

. Perform Product and manufacturing process risk analysis, hazard analysis

and Failure mode analysis

. Conduct internal and supplier audits and help implement audit

recommendations to improve process control

. Implement FDA cGMP and ISO 13485 for Soma technology's remanufactured

devices.

. Conduct IQ/OQ/PQ, statistical process control, Gaze R&R studies and

implement other quality tools to drive continuous improvement in

manufacturing processes

. Develop training programs and train technical and sales engineers in

organizational goals, procedures, regulatory requirements.

. Research Associate(Voluntary)

Bioengineering Department, University of Texas at Arlington

(Aug 2005 to Aug 2006)

. Investigated Polysomnographic ECG data to differentiate rapid eye

movement (REM), hypoapnea and obstructive sleep apnea (OSA) events using

MATLAB

. Extracted and analyzed ECG data clips reflecting OSA, Hypoapnea and REM

events from patient records collected from accredited sleep labs

. Analyzed data using signal processing & statistical techniques and

presented results in a report

. Biomedical Engineer

Jaslok Hospital and Research Center, Mumbai, India

(Nov 2003 to Jul 2004)

. Led a team of biomedical engineers to service medical equipment in

accordance with hospital quality regulation policies to reduce overall

maintenance cost by 50%

. Implement root cause analysis approach to troubleshoot medical devices

and address equipment malfunctions

. Enforced hospital quality assurance policies by auditing safety &

efficacy of medical devices

. Handled different aspects of clinical project management viz. capital

equipment procurement, location preparation, installation, negotiating

service contracts and maintaining documentation

. Facilitated capital equipment purchase by presenting technical cost-

benefit analysis to management

. Biomedical Service Engineer

Lilavati Hospital and Research Center, India

(May 2002 to Sep 2003)

. Serviced wide range of medical instruments by demonstrating strong

analytical and problem solving skills

. Troubleshooted electronic boards of medical devices and validated them to

use in medical devices

. Performed calibrations, preventive maintenance and service procedures on

various medical devices

. Developed training programs for nurses and technical Staff on safety and

operation of medical instruments to keep clinical staff abreast of

advance medical technology

EDUCATION:

. Master of Biomedical Engineering (2006)

University of Texas at Arlington

. Bachelor of Biomedical Engineering (2001)

Mumbai University, India

ACADEMIC PROJECTS:

. PIC18F452 microcontroller based RS-232 to RS-485 transceiver

. Successfully designed & implemented (through software) a duplex RS-232 to

RS-485 converter and RS-485 transceiver with PIC18F452 microcontroller

. Transceiver designed to interface multiple RS-485 external devices

(nodes) under software control.

. Successfully completed tasks of designing, prototyping hardware, software

implementation and debugging

. Heart Rate Monitor Design and Prototype:

. Developed a prototype of instantaneous heart rate monitor based on ECG R

wave detection.

. Developed design specifications, circuit schematics, selected electronic

components according to specification and fabricated a working prototype

. Microelectromechanical Chemical Sensors:

. Comprehensive technical paper presented on MEMS Surface Acoustic Wave

chemical sensors used for detection of chemical vapors and gases.

. Compiled different MEMS fabrication techniques, chemical film deposition

techniques, performance characteristics and applications.

TECHNICAL COMPETENCIES:

Engineering tools: MATLAB, PRO-E, Design-Expert, Minitab

Medical Devices: Anesthesia workstations, Patient monitors, Ventilators,

Sterilizers, ECG machines, Flexible and rigid scopes, Oximeters,

Defibrillators, Surgical microscopes, Blood gas analyzers, Endoscopy camera

systems etc.

CERTIFICATIONS:

. Certified on Draeger medical Narkomed anesthesia machines

. Certified on CAPA, FMEA and ISO 13485 Auditing at Central Connecticut

State University

Contact this candidate