Sun Nuclear Corporation, Software Engineering Manager
June 2012 - Present, Melbourne, FL, United States
Simultaneously managed multiple software development projects. Responsible for project estimation, reporting, execution, and compliance with regulatory and ISO processes. Demonstrated ability to manage teams and execute projects to schedule using Agile and waterfall development methodologies.
- Managed 12 person development team creating a new Patient based Quality Assurance product. Served as Project Manager and ScrumMaster. Project utilized Scrum methodology and was completed on schedule. HIPAA related requirements were defined, managed, and implemented as a part of the project. Created documents to supported the product’s 510(k) submission.
- Implemented Agile (Scrum) methodology on an 10 person development team creating a new Machine (LINAC) based Quality Assurance product. Served as Project Manager and ScrumMaster introducing and educating the development team on Scrum concepts. First Scrum based project at SNC. Project was browser based and completed on schedule.
- Managed 5 person development team completing multiple software releases for the 3D Scanner System. Served as Project Manager implementing waterfall methodology and completing multiple releases on schedule. Projects used Windows Forms and required close interaction with hardware development.
- Managed software releases and patches for multiple products. Project team size ranged from 1 to 5 people. Delivered upgrades included international compliance features, reporting enhancements, and integration with firmware upgrades. Projects were completed on schedule.
- Provided support for the 2013 and 2012 ISO 13485:2003 and ISO 9001:2008 re-certification audit. Interacted directly with auditors in the following areas, System Design, Software Design and Verification, and System Integration, Testing, Design and Development Control. The supported areas had no findings or observations.
Medicomp, Vice President of Engineering
March 2001 - March 2012, Melbourne, FL, United States
Leader for entire Engineering and Technical Services Departments. Responsible for Medicomp’s overall technical direction, design, and implementation of next generation products. Demonstrated ability to hire and build a successful team, create industry leading products, and manage a product through the entire life cycle from concept to manufacturing.
- Directed 8 person in-house engineering team to create, enhance, and maintain multiple successful new products. New products consisted of ambulatory heart monitors, ECG transfer software, automated systems, a patient reports website, and a family of mobile applications. New products developed contribute to the top two sources of revenue for Medicomp’s service offerings.
- Received three FDA 510(k) approvals. Two approvals were for ambulatory heart monitors and one approval was for PC based ECG analysis software, K091696, K090834, and K043454.
- Developed products that transitioned Medicomp from using voice, FAX, and dial-up POTS data collection and distribution to an automated Internet data collection and distribution business model.
- Led implementation of Medicomp’s mobile application product offering including iPhone, iPad, Android, and Windows Mobile applications. The iPhone application was a cardiac monitoring industry first!
- Managed team that delivered next generation Holter monitor to the International Space Station (ISS). Launched to ISS on the Space Shuttle in April 2010.
- Completed design and installation of second Cardiac Monitoring Center in 3 months. The project was completed ahead of schedule resulting in a “Moving Mountains Award” on September 2010.
- Managed contract developers in multiple disciplines, including software, circuit design, and mechanical design.
- Selected and managed contract manufacturers for Medicomp’s products both domestically and internationally. Achieved 48% cost reduction by transitioning cable production to China.
- Served as HIPAA Technical Officer.