PROFILE
- Comprehensive, hands-on experience directing product development teams from inception through to market introduction and product support.
- Proven track record converting requirements from business executives, scientists, engineers, and marketing staff into cost-effective, on-time, maintainable solutions.
- Expert in software quality systems, design controls, agile processes, object oriented design techniques and languages to produce software, components and applications with clear
customer value in highly regulated industries. - My creative insights, engineering versatility, rigorous analysis, and personal leadership have delivered breakthrough products in rapidly evolving industries.
PROFESSIONAL EXPERIENCE
- Created an automated cloud-based testing and validation platform for machine learning software. The platform allowed quick comparison of new models of gene expression used to identify early risk of autism. Established a quality system to support deep learning to identify disease states from pathology images.
- Wrote embedded software alongside fully automated unit / integration tests for the clinical prototype of a needle-less, microprocessor controlled autoinjector. The successful human tests of the device were critical to securing early funding.
- Designed secure communications architectures, controls and protocols for a variety of connected medical devices to support remote monitoring, scheduling, authorization and software update. Established scalable, secure cloud environments for continuous integration, testing, and deployment using infrastructure-as-code.
- Managed a team of robotics software engineers developing new sensors and manipulators for defense applications. Implemented a common set of engineering practices across the three locations to allow innovations to be shared among the teams.
- In-depth expertise in medical device software development and member of the AAMI Medical Device Software Committee responsible for reviewing and approving ANSI/AAMI/IEC 62304 and the AAMI TIR 45 on “The use of agile practices in the development of medical device software”. Lead internal auditor for compliance to ISO standards 13485, 14976, and 62304.
- Led the architecture and design for a high speed, single molecule DNA sequencing instrument with unprecedented performance. Developed critical components and infrastructure to continuously deliver value in a dynamically changing market.
- Evaluated technical and market potential of investment opportunities for new venture capital fund. Review encompassed technology, intellectual property, marketing plans, and operational viability.
- Conducted a comprehensive review of the engineering processes of a leading clinical device manufacturer. The review identified critical deficiencies in quality and project management systems and outlined effective solutions balancing both their technical and business needs while also providing a realistic assessment of the deliverable schedule for corporate planning.
- Developed a universal shopping cart service consolidating order information from any Internet merchant. Converted the business to a successful consulting company when internet business climate changed. Developed the business model, wrote the business plan, and solicited venture capital funding. Established strategic partnerships with analysts and industry trade groups. Secured affiliate agreements with merchants and consolidators. Conducted consumer surveys, test marketing and competitive analysis, established corporate image, and defined product launch program.
TECHNICAL SKILLS and LANGUAGES
| Agile Software Development | C, C++, C# |
| Object-oriented instrumentation | Python, Go, Rust |
| Real-time systems | Javascript, React |