Roberta Goode Email and Phone Number
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Serial entrepreneur, inventor, mentor, biomedical engineer, professor, mother and lobbyist. Founded two companies to improve healthcare outcomes for patients around the world. Four US patents for life-saving cardiovascular applications. Mentor under-represented youth in STEM education. ASQ-certified biomedical engineer with broad experience in all aspects of medical device design, manufacturing, quality and regulatory affairs. Adjunct faculty at George Washington University School of Medicine and Health Sciences and University of Miami College of Engineering. Married to my soulmate with two beautiful children. Fight to expand end-of-life options for terminally ill Floridians, in my mother's honor.
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Regional DirectorFlorida End-Of-Life OptionsPalm City, Fl, Us
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Regional DirectorFlorida Death With Dignity Aug 2020 - PresentFlorida, United StatesFlorida Death with Dignity, a 501(c)(3) non-profit organization, fights to join other U. S. jurisdictions having a death with dignity law, to make it possible for Floridians with a terminal illness to access the same autonomy and individual freedom while dying as they enjoyed while living. We educate the public, healthcare professionals, and legislative communities about patient-directed end-of-life care.
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MemberAcademy Of Science, Engineering And Medicine Of Florida Nov 2021 - PresentFlorida, United StatesThe Academy undertakes studies on issues in science, engineering and medicine of concern to the citizens of the state of Florida, and provides unbiased, expert advice related to these issues.
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MemberFlorida Inventors Hall Of Fame Feb 2022 - PresentFlorida, United StatesBy encouraging scientific discovery, the Florida Inventors Hall of Fame supports a culture of creativity that fuels innovation, drives economic growth, and encourages investment in Florida.
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Adjunct FacultyThe George Washington University School Of Medicine And Health Sciences Jan 2017 - PresentWashington D.C. Metro AreaDepartment of Clinical Research and Leadership -
Adjunct Faculty - College Of EngineeringUniversity Of Miami 1998 - PresentCoral Gables, FlDepartment of Biomedical EngineeringCourses Taught: BME 512 – Medical Device Manufacturing and Regulation Course Description:Medical device manufacturing concepts, emphasizing DOE, process validation, design verification and statistical techniques. Regulatory concepts, including US and European Union standards for Risk Management and Good Manufacturing Practices. Design control, specifically development of customer requirements into specifications, through design verification to design validation. -
Chair, Industry Advisory BoardUniversity Of Miami 2009 - 2014Coral Gables, FlThe Industry Advisory Board consists of a group of professional engineers who meet regularly to discuss the affairs of the Biomedical Engineering Department, in order to maintain its relevance and competitive edge in the industry. Elected to chair 2013.
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Technical TrainerAltrec, Llc Jan 2018 - PresentFt. Lauderdale, FlI delight in simplifying complex topics and communicating them in an engaging, customized format for my clients. Topics include Process Verification/Validation, Design Verification, Risk Management, Statistical Techniques, Designed Experiments, Design for Manufacturability, and more.
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Managing EditorJournal Of Validation Technology (Jvt) Oct 2015 - Jun 2022Greater Boston Area -
Editorial Advisory Board MemberMedical Device Summit Jul 2012 - Jun 2022Newtown, PaMedical Device Summit is an industry-specific online publication serving the global medical device industry.
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Editorial Advisory Board MemberInstitute Of Validation Technology 1998 - 2022The Editorial Advisory Boards of the Journal of Validation Technology and the Journal of GXP Compliance, both journals of the Institute of Validation Technology (IVT), provide manuscripts for the journals, advise on the journal editorial strategy and preferred topics for discussion, review submitted manuscripts, and assist in other journal/IVT initiatives.
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PresidentGoode Compliance International Jan 1993 - Dec 201711606 City Hall Promenade, Suite 204, Miramar, Fl 33025Specializing in medical device manufacturing (Lean, Six Sigma, SPC), process validation (IQ/OQ/PQ), design controls, design verification/validation, packaging/sterilization, test method validation (TMV) and Risk Management (FMEA, HA, FTA, CES, RMP/R). Regulatory services include quality system audits for ISO 13485, Medical Device Directive and CE Marking, filing of 510(k) applications, and compilation of Design History Files (DHF), Technical Files and Design Dossiers. We are particularly effective at bringing in team-based solutions to FDA enforcement actions to remediate 483 and Warning Letter observations.Learn about Goode Compliance http://www.goodecompliance.com -
Advisory Board Member - Partnership ProgramFlorida International University 2009 - 2014Miami/Fort Lauderdale AreaThe Partnership Program is a joint enterprise of FIU, healthcare providers, and biomedical companies. It fosters excellence in biomedical education and training; supports biomedical innovation, invention, and discovery; cultivates biomedical research and development; and promotes biomedical engineering entrepreneurship in South Florida. -
Program ChairBioflorida, Inc. 2002 - 2004 -
Senior Validation EngineerBeckman Coulter Jan 1998 - Jan 1999Established validation policy and implemented validation procedures for consumables manufacturing business unit, requiring detailed knowledge of Quality System Regulation, statistical analysis, design of experiments, in vitro diagnostics, facilities, and manufacturing operations. Responsible for regulatory and scientific validation decisions for world class reagent manufacturing facility. -
Project Leader / Senior Research EngineerBaxter International Inc. / Althin Medical Inc. Jan 1993 - Jan 1998Coordinated diverse business units (e.g., quality assurance, new business development, marketing, manufacturing, research and development, analytical laboratory) to fabricate custom devices for bio-artificial livers, hemoconcentrators and autologous tissue sealants, culminating in key supplier agreements generating over $1.8 million in revenue in 1998. -
Senior Product Development EngineerCordis Jan 1989 - Jan 1993Product development engineer for cardiology production line with a volume of 100,000 units per month. Increased yields on sheath introducer pilot production line by 45% using Taguchi DOE. Identified and implemented technical solution to supplier defect resulting in elimination of a $110,000 daily production shortfall. Discovered novel application for elastomeric material, which was implemented into core diagnostic cardiology product line. Four US patents and Cordis Technical Performance Award followed. -
Product Development EngineerTheratek 1989 - 1991Miami Lakes, FlProduct development engineer for rotational atherectomy catheter product family. Determined optimal operating parameters and characterized cutting surface configuration for multiple atherosclerotic pathologies. Worked shoulder to shoulder with interventional neuroradiologists in cath lab to improve clinical performance of hollow catheters for deployment of embolizing agents for the treatment of AVF in the brain.
Roberta Goode Skills
Roberta Goode Education Details
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Biomedical Engineering
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Pre-Medicine/Pre-Medical Studies
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Biology, General
Frequently Asked Questions about Roberta Goode
What company does Roberta Goode work for?
Roberta Goode works for Florida End-Of-Life Options
What is Roberta Goode's role at the current company?
Roberta Goode's current role is Regional Director.
What is Roberta Goode's email address?
Roberta Goode's email address is ro****@****ech.com
What is Roberta Goode's direct phone number?
Roberta Goode's direct phone number is +195464*****
What schools did Roberta Goode attend?
Roberta Goode attended Massachusetts Institute Of Technology - Sloan School Of Management, University Of Miami, University Of Miami, Palm Beach State College.
What are some of Roberta Goode's interests?
Roberta Goode has interest in Six Sigma, Medical Device Design And Manufacturing, Risk Management, Lean, Critical Thinking, Photography, Statistics, Business Modeling, Astronomy.
What skills is Roberta Goode known for?
Roberta Goode has skills like Fda, Iso 13485, Medical Devices, Quality System, Design Control, Capa, Validation, V&v, Biomedical Engineering, Design Of Experiments, Quality Assurance, Six Sigma.
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