Project And Experience Examples

⇒ Image processing system to analyze blood samples. Consulted on program planning and product technical problem space definition, plus project-enabling technical and business solutions. Led evaluation of external technology design providers.

⇒ For a blood analyzer product family, created a requirements engineering group (peak of 6 staff) and negotiated new process with marketing and program management. With the team, wrote a hierarchically-structured family of traced requirements and risk management documents that was used as a basis for subsequent products.

⇒ Created and brokered solutions for “unsolvable” requirements disputes, bringing feuding factions to consensus agreement.

⇒ Reverse-engineered product and subsystem functional requirements for blood analyzer products where most formal, and much informal, information had been lost. Documents were used by engineering stakeholders to support decision making and impact analysis. Used DOORS, UML, DoDAF and use case approaches to develop and represent the results.

⇒ Strategized Lab Automation product line that included transport system, supervisory system and interfaces between lab instruments and hospital IT. Drove development of customer, product, hardware and software requirements for multiple product family members. Developed customer, field support, and partnering use cases to roll out an OEM lab information system worldwide.

⇒ Architected distributed processing strategy for next-generation in vitro diagnostic instruments analyzer & human interface systems. Treated system quality attributes in human factors, embedded processing, data communications, distributed systems integration.

⇒ Invented a simple, unbreakable encoding scheme & algorithms to authenticate disposables for instruments, driving the solution via use case development.

⇒ Authored a systems engineering standard for 70 person R&D group, then provided a program of training & mentoring to create acceptance and sustainability.

⇒ Conducted over a hundred technical reviews on product-sustaining designs and changes, integrating considerations for system quality attributes (“ilities”), design control, logistics, service & support, and product cost profile. Drove or assisted product CAPA root-cause investigations for hardware, software and reagent failures. Mentored engineering practitioners in identifying and expressing functional requirements specifications and critical quality attributes.

⇒ Conceived, and wrote requirements for, an ultra-low-cost sample-handling workflow guidance system, using wireless, barcode, and optical sensing technologies.

⇒ Used alliance building, influence, and consensus development to realize beneficial change:

♦ Authored software development, maintenance, verification & validation, and SQA processes for 450-person medical device business unit. Implemented or fostered cross-platform enterprise systems for CM, build management, test management, CASE, automated SW test. Led evolutionary updates.

♦ Created software process and practice in at least six significantly complex environments.

♦ Architected medical device Design Control component of Quality System, including integrating IT systems; included information connectivity spanning all levels of requirements, designs and risk management documents, plus meeting and project histories, to integrate DHF and DMR. Drove system development and integration with Use Cases. Trained and mentored over 130 stakeholders and practitioners.

⇒  In various environments, including medical instrumentation development, realized systems solutions for: requirements management (eg DOORS), test management, automated GUI testing, white box branch coverage, defect management, configuration management (including automatic intraweb publication of build derivations, build tree, release notes and version description documentation), communications protocol emulators, instrument simulators, upper CASE (Computer Aided Software Engineering), static code analysis, interactive development environments.

⇒  Defended dozens of major audits and inspections by corporate internal auditors, external ISO assessors, and FDA inspectors. Planned and led major assessments and audits of other organizations, including technology providers.

⇒  Assessed small technology and medical device companies for acquisition by an investment group, including requirements, designs, and capabilities of teams and processes.


Systems Experience Examples From Other Industries

⇒ Programmable Gallium Arsenide molecular beam epitaxy process supervision and control system product for semiconductor manufacturing industry

⇒ Fault-detection system enhancements for a real-time factory floor magnetic (disk) media tester. Also created automated software test utilities.

⇒ Industrial Automation Center Lab Product planning, SQA, and testing, for new release of their real-time relational DBMS. Also created scoreboarding test automation tool.

⇒ System requirements and ultra-high-performance real-time relational database management system for BART Integrated Control System. Reverse- engineered design documents for 250KSLOC supervisory application.

⇒ Systems Control Inc Requirements and design to automate a tire plant for a major manufacturer

⇒ Distributed real-time system for testing integrity and quality of a nationwide telecommunications network

⇒ Enterprise applications for intermodal transportation company

⇒ Requirements & design for real-time pay-per-view WAN controller

⇒ “Upper” CASE tool for object-oriented SW design

⇒ Train Progress Monitoring/Display

⇒ Real-time microwave network monitoring tool

⇒ Real-time automated test engineering system for telecommunications instrumentation

⇒ System audit for Air Freight Operations IT at LAX for a major carrier

⇒ Information system for hospital personnel management

⇒ Market monitoring and forecasting system for inter-modal transportation industry

⇒ Airline reservation system and financial accounting for Northwest Airlines

⇒ Turnkey accounting product for travel agencies

⇒ Desktop app for quantitative nurse staffing QA

⇒ Database application for worldwide hospital staff recruiting

⇒ Shrinkwrap financial accounting product

⇒ Distributed enterprise MIS for nationwide media marketing

⇒ Shrinkwrap product for warehousing inventory and cost accounting

⇒ Refinery maintenance tracking & planning

⇒ Enterprise system to manage group travel packages, reservations, and revenue/cost accounting