Hired to EPT to create and lead a R&D software engineering department for mission and safety-critical software that includes smart battery management system (BMS) solutions. The BMS software monitors and controls the health of Lithium batteries used in military vehicles including jet fighters. To achieve safe, reliable software, a software development process needed to be created and deployed to meet the highest safety standard in compliance with Federal Aviation Administration (FAA). This process is stronger than the Food & Drug Administration Software Classification of Major Level of Concern.In addition to hiring exceptional engineers and deploying a software development process, with my experience in leadership including positions in Senior Leadership Teams, I also brought business concepts and ideas to improve corporate processes including aggregate resource planning across R&D which also includes electrical and mechanical engineering.I celebrated the challenge and today we have a great software engineering team and we are following a strong documented process to deliver safety-critical software.

Working with multiple clients for their compliance with IEC 62304 and FDA regulations of their medical device software and SaMD. Providing guidance and direction on both software architecture and application lifecycle management for creating quality product. In addition, contributing to product requirements, design, and code review and analysis.

With advanced chemistry in good shape, I was asked to work at a Nova Biomedical owners funded startup. I am leading the software development for their first wearable continuous monitoring device. Since the company is a startup, I developed the entire software design control quality system with templates and selected / installed the development tools. We have completed one successful in-house clinical trial on an Android device. We are currently in iOS prototype software development for an external clinical trial.

I was recruited back to Nova for a second time by the owner of the company. With all prior projects in excellent shape, I was assigned to create two different breadboard analyzers to support advanced chemistry development. One analyzer was an electrolyte chemistry strip reader. This device will be used to support point of care testing for cardiac patients. The second analyzer is a single use cartridge device for blood analysis. I leveraged the existing software and architectures from the prior projects to develop these analyzers quickly. In addition to fast turnaround, the software is very reliable due to number of hours under test and it has full data collection / analysis features for chemistry development.

In the short time at T2, we had a small team to update the software SOPs for 62304 compliance. In addition, we delivered a Hemostasis analyzer to customers for the research market. The User Interface was refreshed to be more user friendly. I wish the team the best.

At Nova Biomedical, I led the software development for the Next Generation blood gas analyzers. I was very excited to be invited back to work at Nova again. Responsibilities include scheduling, planning, performance reviews, team training, process improvement, architecture, design, implementation and verification. My mission and vision remains to lead teams for the company to be the “Best In The Industry”. I do not compromise quality and will stand tall. My passion drives us hard in a healthy environment to deliver product. Nova Biomedical is a great place to work.

Taught graduate level course; Advanced Product Design and Development. My lectures involved a case study of product development and FDA Quality System Regulation (Design Control) material. In addition to teaching, I am involved in coaching the students in order to guide them for the delivery of a successful class project.

At Design Mentor, I was responsible for leading the software development for medical devices which included scheduling, budget, planning, architecture, design, implementation, and verification. In addition, I reviewed and improved the development process and interfaced to current clients and potential customers to bring in more business. Verification was performed with an Automated Test implementation that performed the full suite in 3 days. Despite the short timeline at Design Mentor, the team delivered from scratch a Major Level of Concern medical device utilized in surgery which has already received FDA approval. Design Mentor was a great experience working as a contractor. In prior companies, I had utilized contractors, so it was an excellent learning experience to work on the other side. Design Mentor has a very talented CEO, Doug Vincent. If you ever need a consultant for a medical device, I recommend you call Design Mentor.

Earned progressively responsible engineering roles at Instrumentation Laboratory (IL) for the delivery of product to market. Roles included development positions, lead positions, and visionary positions. Development positions required creating requirement specifications, architecture documents, design documents, and source code. Lead positions were hands on and required identifying evals (Sprints) to hit project milestones. In addition, lead positions required constant attention to our process and to continually optimize for performance. Visionary position examined the overall IL product picture and developed a plan that would move IL forward into the future.