Medical Device Design

Tristan Raniga

**** ******* *****, **********, ********** 94588

909-***-**** *************@*****.***

SUMMARY

• Biomedical engineer with experience at a leading medical device company

• Developed two prototypes of an implantable electrical connection using SolidWorks from design concept to design validation

• Background includes product development, research and design, and medical device maintenance

EXPERIENCE

HeartWare Inc., Miami Lakes, Florida August 2013 – May 2014

Master’s Project

• Developed two prototypes of an implantable electrical connection for left ventricular assist device (LVAD) operation

• Responsibilities included: biomaterial selection, connector model design, prototype development and design verification

• Verified prototypes’ electrical, mechanical, and environmental characteristics to determine if they conformed to design

specifications

HeartWare Inc., Miami Lakes, Florida January 2013 – January 2014

Advanced Product Development, Clinical Engineering Intern

• Transitioned inventory control system from MS Excel to a customized MySQL database for company field equipment used

in research studies valued in excess of $15,000 per study

• Validated equipment before use in field studies to guarantee patient safety and effectiveness during operation

• Wrote IFUs, SOPs, and scientific reports after completing experiments to document protocols and procedures

• Designed a fixture for driveline strain relief field service repairs to be used for a future LVAD model

Biomedical Engineering Department, University of Miami, Coral Gables, Florida September 2009 – May 2013

Laboratory Manager

• Maintained functionality of Senior Design Laboratory ensuring students have proper materials for research

• Assisted seniors working on Senior Design Projects by providing assistance during project development

• Provided assistance to Neurosensory Lab by helping design and setup quiet room

• Helped students by operating Stratasys Prodigy Plus (3-D Printer) for graduate research and student project development

Kaiser Permanente, Fontana, California June 2007 – June 2009

Biomedical Engineering Intern

• Inspected and maintained medical equipment throughout the hospital to guarantee patient safety

• Worked on electrocardiograms (ECGs), infusion pumps, and rehabilitation equipment to help hospital staff ensure patient

healthcare

• Managed work orders and product inventory to maintain department standards and hospital maintenance

Keck Graduate Institute, Claremont, California June – August 2008

Summer Intern

• Cooperated on a project to help create a pregnancy-like detection device for HIV/AIDS. Responsible for developing single

use strips for HIV/AIDS diagnosis

• Perfected a lateral-flow reagent dispenser to dispense liquid onto a nitrocellulose membrane strip by adjusting the dispenser

head placement and the electrical output to the motor

• Participated as a member of the RET Program and presented findings at the Southern California Conference for

Undergraduate Research (SCCUR)

SKILLS

• Quality System Standards (21 CFR 820 & ISO 13485), Design Control

• Statistical Methods which includes Acceptance Sampling, Control Charts, and Design of Experiments

• SolidWorks, Minitab, Microsoft Project

EDUCATION

University of Miami, Coral Gables, FL Master

of Science in Biomedical Engineering May 2014

Bachelor of Science in Biomedical Engineering

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