Gregory Keyes Email & Phone Number

Rochester, New York Area

Providing 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.

Rochester, New York Area

Elicited 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.

Rochester, New York Area

Functional 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.

Rochester, New York Area

Lead 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.

Syracuse, New York Area

WA’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.

Rochester, New York Area

Define and develop digital camera reference-design requirements and architecture utilizing client's new processor.

Rochester, New York Area

Various 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.

Rochester, New York Area

Various 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.

Ms, Software Engineering

Project: The Conceptual Integrity Movement, Foundations Of Evalidation And Psychological Safety

Bachelor Of Arts (Ba), Mathematics And Computer Science, Cum Laude

Activities and Societies: Pi Mu Epsilon Math Honor Society; Epsilon Delta Pi Computer Science Honor Society