Gregory Keyes work email
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Gregory Keyes personal email
Over 30-years in medical devices, software, and systems. Roles in programming, software engineering, systems engineering, expert systems/knowledge engineering/artificial intelligence, object-oriented simulation, laboratory automation, remote patient monitoring, blood pressure monitoring, clinical solutions, SDK development, software validation and verification, software process definition and improvement, mathematical modeling, throughput analysis, reliability engineering, people management, team leadership, quality assurance, and...Keywords: MedTech, validation, verification, software engineering, systems engineering, quality assurance, regulatory affairs, management, leadership, software development lifecycle (SDLC), agile, compliance, FDA QSR, QMS, ISO13485, IEC62304, medical devices, risk management, requirements engineering, user experience, customer experience, reliability, expert systems, artificial intelligence, abstraction, complexity, 80/20 principles, conceptual integrity, project management, compliance, UX, CX, analytics, SaaS, API, recruiting, change management, organizational development, software deployment, DevOps
Conceptual Integrity Group Llc
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PrincipalConceptual Integrity Group Llc Sep 2017 - PresentRochester, New York AreaProviding guidance in systems and software engineering practices to identify and mitigate risk. Striving to help you make your products and software defect-resistant by applying a qualitative analytical validation process and enabling you to focus your testing resources and budget where most appropriate. Expertise in interpreting and complying with FDA Quality System Regulation (21 CFR 820), ISO13484 Medical Devices--Quality Management Systems, and IEC62304 Medical Device Software -- Software Life Cycle Processes.
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Principal Systems Engineer / Platform Software ArchitectOrtho Clinical Diagnostics Jul 2014 - Mar 2017Rochester, New York AreaElicited and defined product requirements. Concept modeling: system layout, instrument, throughput, and user experience. External partner and contract management – locally and internationally. Managed and scheduled team of 10-20 engineers. Oversaw development lifecycle deliverables of sub-teams: specifications, test plans, and design documentation. Defined design concepts leveraging and extending existing hardware and software designs, including means of increasing system throughput and reducing hardware complexity and cost. Enabled and oversaw the software team’s transition from waterfall to agile development and usage of associated development tools and philosophy. -
Manager, Software Engineering: Clinical Diagnostics, Immunohematology, Donor ScreeningJohnson & Johnson - Ortho Clinical Diagnostics Nov 2009 - Jul 2014Rochester, New York AreaFunctional manager to 30-40 direct and contract software engineers. Responsible for resource deployment to new programs and sustaining engineering projects. Responsible for complete software engineering lifecycle and adherence of 12 different software baselines – in vitro diagnostics (IVD), clinical chemistry, immunodiagnostics, blood banking, donor screening, tumor cell counting, extracorporeal photopheresis (Class II/III). Responsible for FDA design control compliance (21 CFR 820) and EU design compliance (ISO13484, IEC62304). External partner and contract management – locally and internationally. Project requirements and statements of work. Successful proponent of annual summer intern program as a means to recognize and develop talent as well as prototype tools and technologies. Co-authored product requirements for Ortho VISION Analyzer. -
System Development Lead, Vitros 5600/3600 Clinical Diagnostic AnalyzersJohnson & Johnson - Ortho Clinical Diagnostics Feb 2003 - Nov 2009Rochester, New York AreaLead system development engineer and co-architect for Ortho’s most successful blood analyzer platform (VITROS 5600/3600) and products to-date. Responsible for overall product requirements and design specification definition, schedule management, and guidance/mentoring of hardware and software subsystem teams. Ensured lifecycle documentation compliance with FDA and EU. Defined common design documentation platform strategy for VITROS products.
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Manager/Software Architect, Medical R&DWelch Allyn Nov 1998 - Feb 2003Syracuse, New York AreaWA’s first Software Architect role with evolving responsibility into leadership of cross- functional team of engineers developing innovative clinical software applications, medical devices, office layouts, and workflows for Welch Allyn’s then Office of the Future concept: common hardware/software blood pressure platform, home vitals-signs monitoring devices and services, EMR/EHR-connected medical devices, and integrated clinical desktop. Participation and demonstration at conferences and industry trade shows such as HL7 and HIMSS. Provided software engineering domain expertise in acquisition due-diligence activities. -
Principal EngineerQuestra Corporation Mar 1998 - Nov 1998Rochester, New York AreaDefine and develop digital camera reference-design requirements and architecture utilizing client's new processor.
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Staff Software Engineer, System Throughput LeadJohnson & Johnson 1994 - Mar 1998Rochester, New York AreaVarious software development and leader roles in support of VITROS clinical blood analyzer platform: software architect, analyzer throughput simulation, laboratory automation simulation, and laboratory automation and interfaces. Spear-headed design and architecture thinking and practice based on object-oriented philosophy.
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Team Leader/Software EngineerEastman Kodak Jan 1984 - 1994Rochester, New York AreaVarious software development and leader roles in support Ektachem (pre-VITROS) clinical blood analyzer platform: EKtachem (VITROS) 250 software and electronics architecture, mechanical subsystems software lead, sample pipetting subsystem software engineer, lead system/software engineer first automated sample dilution feature; Ektachem 700 sample programming and other graphical interface applications. Led selection and adoption of cross- development environments, RTOS, SA/SD CASE tools, and electronic document publishing.
Gregory Keyes Skills
Gregory Keyes Education Details
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Software Engineering -
Project: The Conceptual Integrity Movement, Foundations Of Evalidation And Psychological Safety
Frequently Asked Questions about Gregory Keyes
What company does Gregory Keyes work for?
Gregory Keyes works for Conceptual Integrity Group Llc
What is Gregory Keyes's role at the current company?
Gregory Keyes's current role is Mathematician | Computer Scientist | IEC62304 guru | e📈Validator.
What is Gregory Keyes's email address?
Gregory Keyes's email address is gk****@****jnj.com
What schools did Gregory Keyes attend?
Gregory Keyes attended Rochester Institute Of Technology, Seth Godin's Altmba, State University Of New York College At Potsdam.
What skills is Gregory Keyes known for?
Gregory Keyes has skills like Fda, Design Control, Medical Devices, Cross Functional Team Leadership, Product Development, Iso 13485, Quality Assurance, Software Engineering, Software Development, Validation, Team Leadership, Systems Engineering.
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