At Bayer I was hired as part of a team responsible for the release of a new line of equipment for producing medical devices. My main role is to write the documentation required that would allow for someone to successfully operate the equipment and meet all quality/safety requirements. I designed and wrote the operating and cleaning procedures for the equipment, work instructions for any manual assembly and inspection of the devices, the forms required to document inspections/testing, etc. I worked extensively in Bayer's Product Lifecycle Management system to release/approve documentation for the project. I traveled to the site where the equipment was being manufactured and helped perform testing to confirm that the equipment was ready to be accepted by Bayer. In addition to the main project, I helped write 10-20 reassessments for other equipment on the site to confirm whether or not a revalidation of the equipment was required. This involved a process of reviewing the equipment, calibration data, tolerance data, batch paperwork, and maintenance data.I have also helped to execute several protocols and written the final reports for them. This requires coordinating with multiple teams to ensure all required product/packaging is located on sight, overseeing the training of the protocol, and ensuring that the protocol is properly executed by production.

Provide custom pollution control equipment to clients worldwide. My main function is to meet technical deliverables that vary per project, allowing each client to receive a unique product. Day to day tasks include communicating with vendors and clients, working with our process group to understand how each system should be designed, marking up drawings and sketches to support the CAD department in creating each system, and creating and maintaining a bill of materials to support the purchasing department in buying all equipment.

Daily responsibilities involve thorough inspections of parts that are crucial to the function of the medical equipment developed by the company. Also responsible for moving parts to their proper locations after inspections are complete to allow others to trace where and why parts have moved. When parts do not conform, I notify those responsible for production in order to ensure the quality of the product is not compromised.

As an intern at Essential Medical, a start up company located in Malvern, PA, I had a variety of responsibilities involving new and innovative technology. Some days I was working in a clean room, manufacturing and packaging devices. I also worked with other interns to solve problems with the devices, whether it be a manufacturing defect we observed, or something that could help surgeons understand the device better. An R&D area allowed for us to perform tests on devices and collect data, which we would then use to confirm that devices were safe to be used on patients. I was also responsible for inspecting newly bought parts in a QA lab, as well as transporting these parts to the clean room.