Roberta Goode Email & Phone Number

Palm City, Fl, Us

Florida, United States

Florida 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.

Florida, United States

The 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.

Florida, United States

By 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.

Washington D.C. Metro Area

Department of Clinical Research and Leadership

Coral Gables, Fl

Department 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.

Coral Gables, Fl

The 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.

Ft. Lauderdale, Fl

I 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.

Greater Boston Area

Newtown, Pa

Medical Device Summit is an industry-specific online publication serving the global medical device industry.

The 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.

11606 City Hall Promenade, Suite 204, Miramar, Fl 33025

Specializing 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

Miami/Fort Lauderdale Area

The 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.

Established 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.

Coordinated 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.

Product 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.

Miami Lakes, Fl

Product 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.

Certificate In Management And Leadership, Business

Master Of Science (M.S.), Biomedical Engineering

Activities and Societies: Iron Arrow, IVT, ASMEMy graduate research investigated the reduction of suspended particles of atherosclerotic.

Bachelor Of Science (B.S.), Pre-Medicine/Pre-Medical Studies

Activities and Societies: SWE, Psi Chi, IEEE

Associate Of Arts (A.A.), Biology, General