In this position I am the manufacturing engineering representative for one or more medical device production lines. My responsibilities include supporting the production line from an equipment and process standpoint and driving continuous improvement projects. In my role I managed changes on the live production lines including working in the document control system, gaining approval of the change from the different functions and applying the change within the manufacturing systems. I problem solve equipment issues and scrap issues utilizing problem solving tools to identify the root cause and implement a solution. I support quality of the device, leading Non-Conforming Events and Prevention (NCEP) and Corrective Action and Preventative Action (CAPA) as necessary.

I worked as a part of a process development team, assisting in any work that needed completed towards the in-sourcing of a process. I was involved in creating prototype builds, process designing, prototype testing, and started DOE documentation. In a technical report, I developed the test method, conducted testing, and statistically analyzed data for proof of concept testing. In addition, I also completed testing and statistical analysis as a part of a sustaining engineering role.

I performed dry run testing of product to ensure accuracy of design verification test scripts. I researched Terumo Cardiovascular System's technologies to create a comprehensive informational sheet for internal use.

I conducted product performance specification testing, using Minitab statistical analysis to support necessary requirements within ISO 10555-1's specifications. As a part of a team I assisted in assembling design history file documents to support a class III CE mark dossier application. Also a part of the team I contributed to the accumulation of product information and its use in the design of product comparison sheets for market's product reduction plan.