In February of 2018 I changed departments at Jarvik Heart to Research & Development. My focus in this position was primarily on product development. To meet customer needs, I developed various accessories and supporting medical devices for the Jarvik Ventricular Assist System (VAS). I was also involved in the conceptual development and prototyping for early stage products.
I authored design input and output documentation, performed verification and validation testing, and generated regulatory submissions for various countries across the world. It was an excellent opportunity to apply my skills in engineering analysis and statistical analysis, and I was able to thinking critically about new and innovative solutions that would meet the needs of the business and the patient.
I became well versed in design controls under ISO 13485:2016 and FDA's CFR Title 21 Part 820. I also learned to write effective protocols and reports with statistical analyses. Moreover, I learned the value of design and development for a small engineering company. Design and development is a company's long term investment in its future success. To a large extent, development engineers dictate what the company will look like in the coming years. It's this meaningful impact that I've come to find addictive, and it's the reason I'll continue to pursue design and development positions in the future.
Professionally, I was given an abundance of opportunities to present new ideas to higher management and was forced to consider the value of a project from various perspectives. I became comfortable presenting ideas, receiving critical feedback, and reworking these ideas when necessary.