Fixing Broken Hearts: Craig Silverman’s Internship at Edwards Lifesciences

by Craig Silverman, BME ‘08

This summer I worked as a Manufacturing Engineer in the Peripheral Vascular Systems division of Edwards Lifesciences in Irvine, Calif. Edwards Lifesciences is the leader in treating advanced cardiovascular diseases and is the number-one heart valve company in the world. As a Manufacturing Engineer in the Peripheral Vascular Systems division, I focused my work on the production of stents and catheters. A stent is an expandable, laser cut tube that is permanently implanted into the body. The stent is placed in blood vessels that have become obstructed due to the build up of plaque. The purpose of the stent is to maintain an open conduit so that blood can flow. These devices are loaded onto the tip of a catheter and enter the body through the superficial femoral artery. The catheter is then guided through the labyrinth of vasculature until it reaches the blockage and releases the stent.

A Manufacturing Engineer is responsible for supporting the production line. I commonly wrote protocols and reports in order to validate equipment so that it could be used in production. The validations were accomplished by completing a series of qualifications, which ensured that the machine had been installed correctly and was functioning properly. In one case, the equipment did not meet the specifications established by the protocol and it was not allowed to be used for production purposes.

In addition, I established a database and software program to perform statistical process control on all quality test data. Every quality assurance test has specifications, which tell whether or not the measurement passes. This information is useful to track in the long run, as it may provide insight into whether processes are functioning properly. The software program that I worked on monitors quality data over time and provides statistical analysis to show whether or not the manufacturing processes are performing correctly. The software will be essential to increasing overall output and improving efficiency.

I really enjoyed working at Edwards and getting the opportunity to meet many of its great employees. I would highly recommend looking into this company if you are interested in medical devices.