• In this role I reported to the Executive Director of IT and served as the main business analyst on the eTMF3 Trial Master File system which is a SharePoint based application that is hosted and maintained by a third party software vendor.• Gathered high level Epic stories and translated them into detailed User stories that were maintained in Microsoft Team Foundation Server.• Ran the weekly Issue Log meeting to review user problems with the software vendor and determine if they are software bugs or user training issues.• Wrote detailed test cases for the QA team for any new features that got installed.• Provided technical input to the weekly meeting that reviewed open software engineering tickets with the application vendor.• Assisted with high level User Acceptance testing before updates werereleased to production.Tools Used: Team Foundation Sever, Word, Power Point, Visio, UML, Agile, SCRUM

• In this role I reported to the Senior Director of Engineering and I was responsible for maintaining all software requirements documentation at LipoScience, including requirements for all medical devices, the Laboratory Information System (LIS), and software applications used by the Global Research Services department.• Was the administrator of the Cockpit product, which is an automated requirements management tool.• Was responsible for gathering and documenting the software and hardware requirements for the next major upgrade to the Vantera medical device which is LipoScience’s second generation NMR clinical analyzer.• Was responsible for the detailed software and functional requirements and made sure they all traced to proper test cases. Project managers handled the product requirements.• Gathered and fully document the requirements for the Laboratory Information System (LIS) since it was now an integral part of the LipoScience results reporting process and handled the final formatting and reporting of results for Laboratory Developed Tests (LDTs) to remote Vantera installations across the United States via an HL7 interface• LipoScience used a cloud-based service from Axeda for managing secure connections to remotely installed Vantera instruments and I was the administrator of this platform. • Gathered all the detailed software requirements for the next major release of the Study Manager application used by the Global Research Services (GRS) department. They provided LipoProfile test results to CROs that were conducting clinical trials.• Due to my previous experience as a software developer and my attention to detail, the Senior Director of Engineering selected me to be the independent reviewer of all major software releases.Development Tools Used: Cockpit Requirements Management Tool, Enterprise Architect, Visio, UML, and Axeda M2M Enterprise Communication Platform

• My primary responsibilities were to assist with the development of the Vantera software and enhance the NMR Profiler analysis applications. The NMR Profiler is used by LipoScience to perform the LipoProfile test and it is FDA 510 (k) cleared for clinical use. • Designed and coded an entirely new Assay Server application in .NET that allowed the NMR Profiler to produce test results for both the LipoProfile II and the LipoProfile III assays from a single sample.• Have extensive experience working in an FDA regulated development environment, authoring requirements and documentation for 510 (k) submissions, and adhering to a development process that follows full design controls and is 21 CFR compliant.• After the code development phase of a project was complete I assisted the QA department with writing and executing the verification and validation test protocols.• Assisted with the development and testing of the Remote NMR Analyzer that was deployed to the Mayo Clinic for research purposes. I authored the software requirements specification and shared in the testing effort. I travelled to the Mayo Clinic and executed the Installation Qualification (IQ) after a service technician had the instrument set up and configuredDevelopment Tools Used: C# .NET, ADO.NET, ActiveX, SQL Server 2012, Active Reports, Subversion, FogBugz, UML, and Enterprise ArchitectEnvironments: Windows XP

• My primary responsibilities were to manage the development of the next version of software for Global Research Services (GRS) and maintain the NMR Profiler medical device.• Authored the software requirements and design documents for the Study Manager System used by GRS, shared in the coding, and assisted with the writing of the test protocols.• Assisted with the testing and documentation of the NMR Profiler medical device Development Tools Used: C# .NET, ADO.NET, VB.NET, Visual Basic 6.0, ActiveX, SQL Server, Active Reports, Visual Source Safe, UML, and Enterprise ArchitectEnvironments: Windows XP

• LipoScience implemented a new Laboratory Information System (LIS) that required an updated interface to the NMR instruments in the lab. After gathering and documenting the software requirements, I designed and coded the application in .NET. This interface formatted test results according to the ASTM communication standard and transferred them to the LIS using TCP/IPDevelopment Tools Used: VB.NET, ADO.NET, Visual Basic 6.0, ActiveX, SQL Server, Active Reports, Visual Source Safe, UML, and Enterprise ArchitectEnvironments: Windows 2000 Professional and XP

• Worked on their EMR (Electronic Medical Record) product which was a clinical charting application that could run on a remote pen unit and communicate with the main database via radio frequency. • Was the lead developer for the Insert Lab Values project which allowed doctors to insert the most recent lab results for X-ray, blood work, urine analysis, etc. directly into a patient’s chart note.• Worked along with the architecture team and assisted in designing an N-tier architecture that would allow us to easily move our VB 6.0 code to .NET by adopting a service - oriented architecture (SOA) based upon the HTTP request/response standard.• Was selected to represent our team on the Talon Project doing research, analysis, and requirements gathering for the next generation software release that would integrate the Misys EMR and Practice Management systems into a single product.• Due to my relational database and SQL experience I was selected to represent our department on the Data Model Project team and I handled all of the code, database and index optimizations for the EMR product.Development Tools Used: VB.NET, C# .NET, ASP.NET, ADO.NET, Visual Basic 6.0, ActiveX, SQL Server, Active Reports, Visual Source Safe, UML, and Enterprise Architect, Agile, SCRUMEnvironments: Windows 95/98, Windows NT, 2000 Professional and XP