My main work efforts during my time at Biogen centered around increasing the capabilities of the device lab through the development of fixtures and associated work instruction documents. I was charged with viewing the testing efforts holistically, starting with understanding the data to be generated and ending up with a fixture and document ready for testing.
The start of my work efforts would begin with understanding the data to be generated. During my time at Biogen, this was usually break-loose and extrusion force (BLEF) or rigid needle shield (RNS) removal force data. Once the data was understood, I would begin to design the fixture. For certain projects this involved starting from scratch or from a general concept. For other projects, I was able to begin with a fixture that had been manufactured by an external vendor that would need to be adapted for use in our lab. This process involved making sketches and measurements of the fixtures, as well as modeling in SolidWorks. Through this effort, I experienced growth in my SolidWorks and 3D printing capabilities as well as in my overall mindset in engineering design.
Fixtures, while important, are only a part of the overall testing effort. Another crucial component is the work instruction. I was responsible for writing these documents for the fixtures I designed. While working on this effort, I found it to be very important to co-develop the fixtures and work instructions. Thinking about how I would communicate the use of the fixture to the operator as I designed it allowed me to create final designs in fewer iterations. Similarly, having the specific details and use of the fixtures in mind while I wrote the instruction allowed me to indicate more clearly my intent for proper use of the fixture. In this way the fixture became an input to the document, and vice versa. Overall, I learned that this co-development streamlines the test method development process while vastly increasing the quality of the final product.
While designing fixtures and documents that I would also be the user of, I learned and thought a great deal about the design process. I also gained confidence and experience with prototyping and iterating while working on and designing fixtures.