Ten Steps from Pupil to Proprietor

Date(s) - 09/24/2018
3:00 pm

Roberta Goode, M.S., President, Goode Compliance International

Driven by global requirements to recruit engineers fluent in several regulatory charters, life science companies have raised the bar for incoming BME graduates. Once the staff position is attained, today’s young biomedical engineers prefer flexible hours and work/life balance over job security and healthcare benefits, making them increasingly open to entrepreneurial pursuits. In this presentation, I will provide a ten-step process for the evolution of BME grad to corporate engineer to CEO/founder. Together, we will explore the importance of identifying and filling key gaps in our knowledge, building a professional network, and leveraging best practices for launching a start-up entity. These tips are relevant for students preparing for jobs in industry, for faculty partnering with outside consultants, and for every entrepreneur temporarily masquerading as an employee.


Twice awarded IVT’s Speaker of the Year, Roberta Goode is an ASQ-certified Quality Engineer and a serial entrepreneur.  With nearly 30 years of experience in research & development, quality engineering, and manufacturing engineering, Roberta’s qualifications include a graduate degree in Biomedical Engineering from the University of Miami, a Certificate in Management and Leadership from MIT Sloan School of Management, four US patents for novel cardiovascular devices, and adjunct faculty appointments at the University of Miami’s College of Engineering and The George Washington University School of Medicine and Health Sciences.

In 1998, Roberta developed the first Quality Systems course for biomedical engineering students at the University of Miami. The curriculum centered on practical tools and regulatory affairs for graduating students. In 2000, this course was accredited by the Accreditation Board for Engineering and Technology (ABET), who recognized it as a pivotal course that bridged a gap between academia and industry.

In 2002, Roberta founded Goode Compliance International, LLC. Under her leadership as president, GCI created 350 jobs, generated over $50 million in sales, and remediated FDA enforcement actions for 17 of the 20 largest medical device manufacturers in the world.

In 2018, she formed Altrec, LLC, with the mission of sharing knowledge, mentoring the next generation of biomedical engineers, and improving patient outcomes through a unique collaboration with the US Food and Drug Administration.