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Biomedical Engineer, Quality And Regulatory Affairs Engineer

San Francisco Bay Area, California, United States
November 02, 2018

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*** ***** ***, ***** *****, CA *5054



Actively seeking a Full-time or internship/ co-op opportunity in the Medical Device industry.


The University of Texas at Dallas Aug 2016-May 2018

Master of Science in Biomedical Engineering GPA: 3.89/4.0

Gandhi Institute of Technology, Visakhapatnam, India June 2015

Bachelor of Technology in Electronics and Instrumentation Engineering GPA :3.68/4.0







Network Analyzer, Function Generators, Oscilloscopes, Multimeters

Risk management (dFMEA), FDA,21CFR part 820, ISO 13485, IEC60601-1, Design controls, DHF, CAPA, SOP, Verification and Validation, Six Sigma methodologies: DMAIC, Lean,SPC, root-cause analysis methods.


Medical Device Regulation and Regulatory Strategy

1. Spinal cord stimulator regulatory strategy– Using critical thinking, interpretation, and analytical skills, worked as a team member to create regulatory strategy for delivering an implantable spinal cord simulator to market in the US (FDA) and in Russia (MDD).

2.Gained familiarity with De-novo, 510k, and PMA submissions, Health Hazard Form, Global regulatory pathways (EU, Canada, Australia), CE Marking, Health Hazard Evaluation, Notified Body

Quality Management Systems-

1. Implementation of Quality System Regulation (QSR) requirements for a product development in medical device industry. Gained familiarity about Product Lifecycle and Project Management, Complaint Handling

2. Working knowledge of Design Controls, Process Validation, Production Control and NC material handling, Purchasing Control and Acceptance activities, SOP and CAPA, GMP, Internal Audits, Documenting Complaints

3. Created an SOP for process validation activities (involving IQ, OQ, PQ), equipment installation and calibration.

4. Designed various Quality subsystems (CAPA, QMS Purchasing control & Acceptance Activities, Production and Process Controls) and Developed a quality manual by integrating all the subsystems.

Heart Beat Monitoring using MSP430 from Fingertip- Designed a two-stage, high gain, active low pass filter using Op-Amps to filter and amplify the signal: PCB design (Eagle) and Embedded C.

Acquire and analysis of breathing rate-Designed hardware to acquire, filter and amplify the vibrations and an extensive LABVIEW code for separating heart and lung sounds.


Aug 2018- Present

June 2018- July 2018

(2 Months)

(3 years)

Biomedical Engineer Intern-MicroCube (Fremont, San Francisco, California)

1. Verification and Maintenance all Complaint Logs of returned and damaged products for Quality check & Requested investigations for few Product Failure cases, did Root Cause Analysis and initiated CAPAs.

3. Filling FDA Form 3654, Complaint Handling, Inspecting finished products and Non-Conformance Reporting, Internal Audits. Testing Class 3 Medical Device according to SOPs & Quality Manual.

Quality Engineer Intern- nView Medical (Salt Lake City, Utah)

1. Testing and assessing medical equipment according to IEC60601-1, ISO 13485 Medical Device Standards of an X-ray machine, Conducting Design Reviews. Instrument- OMNIA II (Electrical Safety Tester).

2.Developed Design Controls and Verification Protocol documents for 510(k) submission

3. DHF-Documented User Inputs according to IEC62366, Risk Assessment and Design Planning

Aug 2017 – May 2018

Oct 2016 – June 2017

Aug 2015- May 2016

Research Assistant (Biomedical Micro devices and Nanotechnology Laboratory)- UT Dallas, Richardson TX, USA

Design a portable sleep apnea monitoring device using Arduino and IoT Platform. The objective is to monitor breathing rate and cardiovascular diseases due to sleep apnea and to send the signal to the phone.

Quality Assurance Intern - UT Dallas, Richardson TX, USA Q

1. Reviewed Medical Device quality case studies, risk management principles, developed regulatory strategies for medical devices based on ISO 13485, 21 CFR 820, ISO 14971,ISO 9001,MDR

2. Acquired knowledge on CAPA process using root cause analysis (5 Whys, Fishbone Diagram, Pareto analysis, ANOVA, FMEA), Risk analysis,Risk Estimation,Risk Evaluation and Risk Control Measures

3. Gained familiarity about process validations (IQ, OQ, PQ) and developed protocols and product development performance effects using FMEA techniques, Fault Tree Analysis for product quality.

Design Engineer, Radiant Technologies, Visakhapatnam, India

1. Tested speckle noise filtering algorithms for processing ultrasound images using MATLAB. Designed thin wall bifurcated, tumor veins with different diameters using SOLIDWORKS and 3D Printed it.

2. Drafted SOP’s for subparts in 21 CFR 820 (Design analysis, Risk management, Verification of purchased product, In process & Final inspections, Control of Non-conforming product, CAPA)

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