Reliability Engineer

RAMYA RAMESH

**** *** ******* ***, *** ****, Santa Rosa, CA-95403 Email: *****@***.*** Phone: +1-323-***-**** PROFILE

Biomedical engineer with industry experience in applying medical device quality standards and focused on delivering quality controls and enhancements to proactively address problems and improve product quality. Detail oriented, well versed with Risk Management tools and experienced in Good Documentation Practices (GDP). SKILLS

Quality Tools: Minitab, FMEA, Statistical Process Control (SPC), Design Control, Validation and Verification, Gage R&R, CAPA

Medical Product Regulations: 21CFR820, ISO13485, ISO14971

Programming and Simulation tools: Matlab, LabView, Multisim, Partsim EDUCATION

The University of Southern California GPA: 3.8/4.0 Masters in Biomedical Engineering December 2015

Anna University GPA: 4.0/4.0

Bachelors in Biomedical Engineering May 2013

WORK EXPERIENCE

Reliability Engineer at Medtronic, Santa Rosa, California February 2016-Present Supported DVT (Design Verification Testing) on Transradial (Class II) products and ensured testing was performed in conformance with the test protocol. Supported shelf life testing and performed root cause analysis for the failures encountered, suggested corrective actions and drafted PDR (Product Deviation Reports) and observation forms. Authored and released design verification reports, shelf life reports, marketing test protocol and report for Transradial products. Coordinated with different sites and multiple support groups to test predicate product for establishing substantial equivalency to support pre-market approval submission (510k) to FDA. Led test method validation activities for next generation DCB

(Drug Coated Balloon) products. Updated risk documents (FMECA, RMR and PSL) and reviewed component qualification reports for Class III products.

Component Development Intern at Medtronic Tempe, Arizona August 2015-December 2015 Qualified and characterized thin film inductors for the Bluetooth matching circuit of a cardiac resynchronization device. Used Minitab to determine Cpk and Ppk and to identify trends and patterns. Created test fixtures, performed Gage R&R on the Keysight 34420A microohmeter and software validation on the LabView module used to acquire DC Resistance from the inductors. Collaborated with suppliers on an ongoing basis to guarantee consistent high quality performance.

System Engineering Intern at Medtronic, Culver City, Los Angeles January 2015-May 2015 Provide an optimized solution for the e-signature tool to comply with HIPAA and 21 CFR 11 regulation standards. Studied the correlation between the values illustrated by the Accuview software and by the physicians to verify the overlap refluxes commonly interpreted by the physicians and software. Created a database of reflux monitoring products to understand the competitors, market share and the economics of demand & supply. Created and released linguistic test protocol and worked closely with the language translation company to translate the Accuview software in eleven different languages.

Research Assistant at Indian Institute of Technology, Madras, India August 2012-March 2013 Designed and developed an artifact free respiration monitor using Impedance Pneumography and LabView. Implemented an excitation source using amplitude controlled Wien bridge oscillator, constant current source circuit with a four and eight resistor phantom model. Collected respiratory data from thoracic phantom models and developed algorithms for automated Respiratory Rate detection.

PROJECTS

Heartware’s ventricular assist device recall Fall 2015 Identified the hazards associated with the recall and created a fishbone to identify potential causes of the hazard. Assessed the product risk using FMEA’s, evaluated the hazard and provided a risk mitigation plan to reduce risks.

Measurement System Analysis and Control Charts Project Spring 2015 Developed a testing system to assess the time of flight for paper projectiles and authored a Standard Operating Procedures

(SOP) for the operators to perform a Gage R&R to understand variations in the measurement system. Analyzed stock data using control charts and interpreted the data to analyze the trends in Minitab. ACHIEVEMENTS AND PUBLICATIONS

Conferred the ‘Chairman’s Medal’ for securing 1st Rank in Biomedical Engineering among 500 schools under Anna University, India.

Awarded ‘Best Outgoing Student Award’ for overall excellence in academics, sports and extra-curricular activities by SSN College of Engineering from 2009-2013.

‘Development of Movement Artifact Free Respiration Monitors using Impedance Pneumography and Analysis Using Lab View’, Indian Conference on Applied Mechanics (INCAM) 2013 IIT Madras, ISBN ***-**-****-273-8, July 2013.

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