Hello, I’m Thi Nguyen and I have been working in the medical device industry for more than 15 years.

I started my quality profession in design control and production, then set up quality systems from the ground up while continuing to be the lead quality engineer on multiple products. This experience later led me to work on regulatory strategies, writing 510(k)s, and letter-to-files for products of various therapeutic needs. I have stayed within the start-up to small organizations so I have worn multiple hats. I have been able to understand the perspectives of various departments and this helped me to create right-size processes as well. 

I started Habit 2 Mindset to support companies with their goals. The name comes from “Habit 2: Begin with the end in mind” which is a principle from Stephen Covey’s book The 7 Habits of Highly Effective People. The general principle of this habit is taking the mental idea of the end goal and creating physical actions to achieve the result. That summarizes my work ethic. With this principle, I have helped launch a wearable breast pump, obtained an FDA-cleared status for a urine monitoring system, was involved in starting an augmented reality spine surgical clinical study, and implemented production improvements to improve product quality.   

Please check out my resume for additional details.