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Dashboard Members Roberta Goode
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Roberta Goode is a visionary leader and accomplished entrepreneur at the intersection of biomedical engineering, public policy and innovation. Her unique journey began at the age of sixteen, while pursuing a pre-med bachelor's degree and working as a programmer analyst to fund her education. Initially aspiring to a career in medicine, she recognized the transformative power of technology in healthcare. This insight led her to pivot, earning a Master of Science degree in Biomedical Engineering in 1991. Goode’s graduate research focused on biomechanics in the reduction of suspended human arterial tissue particles in rotational atherectomy interventions for the treatment of vascular occlusions. She discovered the relationship between the operating characteristics of the device (angular velocity, rotational speed, and fluid flow rate) and the histology of vascular tissue at the treatment site, leading to optimization of interventional vascular procedures that extended countless patients’ lives. The atherectomy device was manufactured by Cordis Corporation (a Johnson & Johnson company), which recruited Goode into a product development role upon her graduation. By age 28, Goode was promoted to a senior role in medical device commercialization and had secured four U.S. patents for novel cardiovascular device designs that saw worldwide clinical adoption, affirming her early impact. Shortly thereafter, a pivotal realization shifted her focus from individual patient care to impacting lives on a broader scale through medical device innovation.
Joining Baxter Healthcare's Renal Division, Roberta expanded her expertise to encompass manufacturing, quality assurance, and regulatory affairs. Her talent for engineering and business acumen quickly propelled her into a leadership role, championing the commercialization of diverse medical applications—from wound sealing to artificial liver bioreactors. Her involvement in contract negotiations and business development further honed her strategic capabilities. Leveraging this comprehensive experience, she founded Goode Compliance International (GCI), an engineering services firm specializing in resolving regulatory enforcement actions for medical device manufacturers. Armed with certifications as a Certified Quality Engineer (American Society for Quality) and a Certificate in Management and Leadership (MIT Sloan School of Management), she built GCI's corporate compliance division from the ground up. Under her leadership, GCI established robust corporate quality systems, patient-focused risk management processes, and state of the art validation strategies that were recognized by the FDA and EU’s Notified Bodies as best practices in the industry.
Her extensive network from industry and adjunct faculty appointments at the University of Miami and George Washington University fueled GCI's rapid growth, when Goode recognized she could dramatically expand GCI’s services and simultaneously provide professional development to top engineering graduates from Florida’s universities. Goode implemented an innovative business model to mentor recent biomedical engineering graduates, preparing them to tackle complex regulatory enforcement challenges in the biotech industry. In just eighteen months, GCI expanded from a single staff member to sixty-five engineers, ultimately creating over 350 jobs at GCI’s headquarters in Broward County, Florida, and earning a client base consisting of 17 of the 20 largest medical device manufacturers worldwide. Guiding global medical device companies to resolve significant product quality and regulatory restrictions has profoundly improved the quality and safety of countless patients' lives around the world and created a pipeline for training and job placement of Florida’s top engineering graduates in professional and purposeful careers that serve society.
Goode serves on multiple Editorial Boards, Advisory Boards, and Boards of Directors, including Florida’s Academy of Science, Engineering and Medicine. She is an active contributor to the Ignite STEM mentorship program and is a Regional Director for Florida’s End-of-Life Options non-profit organization, where she participates in legislative advocacy on behalf of terminally ill Floridians. Additionally, Goode is the recipient of many academic and industry awards, including UBM/Advanstar’s Speaker of the Year, NACUBO’s Best Technical Training Program, Excellence in Career Education by Toppel, the Ozcan Ozdamar Distinguished Biomedical Engineering Alumni Award, UM’s College of Engineering Distinguished Alumni Award, and FIU’s Internship Dean’s List. In recognition of her impact, Goode was elected to the Florida Inventors’ Hall of Fame; the Academy of Science, Engineering and Medicine of Florida; and the Iron Arrow Honor Society – the highest award bestowed by the University of Miami and the Miccosukee Tribe of Indians of Florida.
Overcoming childhood poverty, Goode was the first in her family to earn a college degree. Today, her purpose is to inspire and uplift others through compassionate advocacy, scientific literacy and creative exploration of nature, while embracing personal growth and fostering meaningful human connections.
Joining Baxter Healthcare's Renal Division, Roberta expanded her expertise to encompass manufacturing, quality assurance, and regulatory affairs. Her talent for engineering and business acumen quickly propelled her into a leadership role, championing the commercialization of diverse medical applications—from wound sealing to artificial liver bioreactors. Her involvement in contract negotiations and business development further honed her strategic capabilities. Leveraging this comprehensive experience, she founded Goode Compliance International (GCI), an engineering services firm specializing in resolving regulatory enforcement actions for medical device manufacturers. Armed with certifications as a Certified Quality Engineer (American Society for Quality) and a Certificate in Management and Leadership (MIT Sloan School of Management), she built GCI's corporate compliance division from the ground up. Under her leadership, GCI established robust corporate quality systems, patient-focused risk management processes, and state of the art validation strategies that were recognized by the FDA and EU’s Notified Bodies as best practices in the industry.
Her extensive network from industry and adjunct faculty appointments at the University of Miami and George Washington University fueled GCI's rapid growth, when Goode recognized she could dramatically expand GCI’s services and simultaneously provide professional development to top engineering graduates from Florida’s universities. Goode implemented an innovative business model to mentor recent biomedical engineering graduates, preparing them to tackle complex regulatory enforcement challenges in the biotech industry. In just eighteen months, GCI expanded from a single staff member to sixty-five engineers, ultimately creating over 350 jobs at GCI’s headquarters in Broward County, Florida, and earning a client base consisting of 17 of the 20 largest medical device manufacturers worldwide. Guiding global medical device companies to resolve significant product quality and regulatory restrictions has profoundly improved the quality and safety of countless patients' lives around the world and created a pipeline for training and job placement of Florida’s top engineering graduates in professional and purposeful careers that serve society.
Goode serves on multiple Editorial Boards, Advisory Boards, and Boards of Directors, including Florida’s Academy of Science, Engineering and Medicine. She is an active contributor to the Ignite STEM mentorship program and is a Regional Director for Florida’s End-of-Life Options non-profit organization, where she participates in legislative advocacy on behalf of terminally ill Floridians. Additionally, Goode is the recipient of many academic and industry awards, including UBM/Advanstar’s Speaker of the Year, NACUBO’s Best Technical Training Program, Excellence in Career Education by Toppel, the Ozcan Ozdamar Distinguished Biomedical Engineering Alumni Award, UM’s College of Engineering Distinguished Alumni Award, and FIU’s Internship Dean’s List. In recognition of her impact, Goode was elected to the Florida Inventors’ Hall of Fame; the Academy of Science, Engineering and Medicine of Florida; and the Iron Arrow Honor Society – the highest award bestowed by the University of Miami and the Miccosukee Tribe of Indians of Florida.
Overcoming childhood poverty, Goode was the first in her family to earn a college degree. Today, her purpose is to inspire and uplift others through compassionate advocacy, scientific literacy and creative exploration of nature, while embracing personal growth and fostering meaningful human connections.