Programming for AllThis undergraduate non-major course addresses programming fundamentals using the Python programming language: data, variables, selection, loops, arrays, input/output, basic graphics and functions. Object-oriented design: encapsulation, objects, classes and methods. Graduate Special Topic: Computer Networks and SecurityThis graduate course is a comprehensive treatment of Computer Networks including the depth of all network layers and the breadth of all manner of internetworking. We consider capabilities including applications/services/clouds, transport, routing/switching, internetworks, and wired/wireless physical connections. The primary goal is to develop a comprehensive understanding of “how things work” in complex systems with reliability and interoperability as important goals. In addition, topics related to security, especially in the context of network services, are considered.

Founded firm to help organizations make sense of the complex and challenging, find a better way to address their business challenges. With this deeper understanding, they improve their business positioning and, in the process, save them money and time in these unprecedented times.SAMPLE ENGAGEMENTS• Advised a Manufacturing startup in creation of a Business Model Canvas following principles from Steve Blank's book on the topic. Pro Bono activity with a National NSF i-Corps team.• Retained to assess Digital Health project and develop a remediation plan relative to the intersection of strategy and technology.• Engaged to develop and apply procedures for Software Quality (62304/13485/14971) for multiple healthcare clients. Why? Avoid anticipated audit trouble and facilitate regulatory clearance.• Consulted to assess, define and implement a technology strategy for a data management organization.

Hired by CEO and by VP of R&D to drive the development of multiple client medical devices and Software as a Medical Device (SaMD) projects, and several development process projects, within this ISO 13485 certified organization.CONTRIBUTIONS• Applied IEC 62304-compliant software development processes to planning and execution for development, with consideration of ISO 14971 and IEC 62366-1 requirements.• Created and delivered training for Correction and Preventive Actions (CAPA) processes.• Addressed Cybersecurity topics including Software Bill of Material (SBOM), build processes, and identity/access management.Applying IEC 62304-compliant processes to planning and execution for development, with consideration of ISO 14971 and IEC 62366-1 requirements.

Hired by VP of R&D to lead a multi-site Agile methodology R&D team for sustaining, acquiring,and organically developing hardware/software for their largest business unit, Vascular Access.CONTRIBUTIONS• Succeeded in due diligence then integration of acquired product andcompany, and in the evolution of a prior acquisition into a fully sustainingmode. Launched new product from acquisition, and developing follow-onsincluding full treatment of cybersecurity topics, ultrasound imaging, and PACS/EMR connectivity.• Contributing to post-market surveillance, quality, regulatory, and operationstopics for existing products.• Transitioned key product technology to a more sustainable platform, savingmany millions of dollars.• Resolved issues requiring a balanced mix of technology and processunderstanding (FDA Design Controls 21 CFR 820.30, ISO 13485, IEC 62304,IEC 62366, ISO 14971, IEC 60601-1)• Introduced new capabilities for usability/human factors topics andcybersecurity topics.• Key player in patent/intellectual property strategy.• Developed partnerships with talented contract development/manufacturingorganizations.• Completed investigation and closure of three long-standing CAPAs, and onefast-closed highly technical business-critical CAPA.

Recruited to develop regulated medical devices and monitoring systems for this start-up jointly funded by Intel and GE. Led team that developed both hardware and full stack software including embedded devices.CONTRIBUTIONS• Directly contributed to use-case requirements, design review, test/verificationand design transfer.• Drove healthcare data aggregation and analytics product development andclinical evaluation.• Guided development of new hardware: schematic capture, bill of materials,layout, prototype, evaluation.• Drove compliance-related (UL/FCC) testing/updates as required for ongoingdevice availability.• Deployed RESTful web interfaces for data and message exchange.• Identified new approach for system implementation using commercial“Internet of Things” (IoT) technologies.• Received award for success in transition of a core development team from anoffsite location.• Effectively structured and used defect tracking, document management andsource code control systems.• Maintained compliance to ISO 13485, ISO 14971 and CFR 820.30 processesfor Medical Device development.• Developed site review and survey approach for network deployment resultingin 50% cost reduction.• Received award for transfer of manufacturing from offshore to USA;optimized test coverage and yield.

Business Unit leader hired me to create automated medical devices (capital / consumable) for use in hospital environments. Defined requirements, performed assessments and drove progress.CONTRIBUTIONS• Led formal medical product risk assessment (team of engineers andphysician). Identified and corrected key gap in hardware architecture, avoidingpotential product recall.• Drove development of hardware and software/firmware changes to supportnew system controls and UI.• Turned around $10M project. Moved project to successful beta within 10months of hire, securing testimonial from regionally influential customer.(Projected sales of $25M annually.)PRIOR EXPERIENCEBayer HealthCare, Diabetes Care (now Ascensia), Tarrytown, NY (3 years)R&D Director, Software DevelopmentSiemens Healthcare (now Cerner) (2 years)Director, EngineeringLifeScan, Inc., Johnson and Johnson, Milpitas, CA (1 year)R&D Director / Segment LeaderQSPP Group, Lancaster, PA (5 years)PrincipalPolycom, Inc. Milpitas, CA (1 year)VP EngineeringLifeScan, Inc. Johnson and Johnson, Milpitas, CA (3 years)R&D Director, Software and Data ManagementWise Medical Systems, Los Gatos, CA (2 years)VP EngineeringAcuson, Acquired by Siemens, Mountain View, CA (3 years)Engineering ManagerE-Mu Systems, Los Gatos, CA (1 year)Systems Engineering ManagerROLM/IBM, Austin, TX, Santa Clara, CA (8 years)Engineering ManagerHewlett-Packard, Cupertino, CA, Sunnyvale, CA (4 years)Production Engineering SupervisorR&D Member of Technical Staff