SUMMARY:

• Engineer with 20 years IT experience (12 software engineering / project lead, 5 technical / field support). Success in developing software in a heavily regulated healthcare environment, adhering to strict FDA guidelines and design controls.
• Team leader and mentor for initiatives merging multiple products and disciplines, spanning global product lines and groups; It was quite common to work closely with marketing, manufacturing, development, SQE, learning products, and field teams. Success meant traceability from inception, to release - working on and creating CRS, SRS, ES, and IS documents, using tools such as Requisite Pro and ClearQuest.
• My current employer is going through a reorganization, and as a result, our facility is being phased out in the coming months. I am seeking a position in software engineering, software quality assurance, or technical support (field, desktop support, IT project/team lead).

TECHNICAL SKILLS:

• Microsoft C#, Microsoft VB.NET, Microsoft .NET, Winforms, Installshield, Clickonce, MSSQL, MySQL, Java script, VBScript, Windows Server, Windows Desktops, Citrix, Requisite Pro, ClearQuest.

PROFESSIONAL EXPERIENCE:

Confidential

Senior Software Engineer

Responsibilities:

• Key contributor for product traceability, risk assessment,
• Authored test specifications (test plans, test cases, anticipated outcomes)
• Authored test tools to support testing automation
• Wrote code for next generation product
• Handled configuration management for legacy product line

Confidential

Software Engineer

Responsibilities:

• Key contributor for CRS, ES, SRS, and IS specifications
• Authored test specifications (test plans, test cases, anticipated outcomes)
• Design verification (intended use cases, V&V)
• Risk management (RMS, PSRA) and root cause analysis
• Dealing with new emerging markets as they relate to new features in a class 3 medical device
• Been involved in 510k submissions
• HIPAA compliance for intended customer-base
• Been involved in CAPA's
• Combo tower conversion to blade: Worked as a key member in converting our legacy “stand-alone” tower server to HP Blade systems. This required extensive code changes in the main C# frontend, C# backend, and SQL Server 2005 stored procedures. This also required a thorough rewrite of our Installshield installation package to support one installer that deployed application binaries, database binaries, or both. It also needed to support seamless upgrades with minimal downtime.
• Software only system and activation licensing: Worked almost entirely as one, to offer a software-only solution from our turnkey offering. The installer was overhauled to be more robust and anticipate unknown variables introduced by new target platforms. This project led to the creation of our licensing model to protect IP and also offer a limited “trial/demo” of the product. In conjunction with an online ASP tool for license key generation, the success of this project eliminated the need for turnkey systems all-together and has had a positive financial impact on builds coming from the factory and time-to-implement in the field.
• Desktop “light” product offering: Worked as the primary lead on crafting a solution for our smaller doctor’s clinics that was aimed at laptops and/or desktops. This project required the enterprise system to remain intact while building upon the C# code to implement (hide) functionality not required of smaller clinics. As well, this required a completely new installation package that supported complete integration of SQL Express, IIS, MSMQ, and various other Windows components.

Confidential

Software Engineer

Responsibilities:

• Student services website support: worked as a contributing member for our student services portal. This portal was written in ASP Classic using VB.NET, vbscript, javascript, and utilized a SQL Server 2000 backend. The university student base of 22k was supported entirely by our IT team of 3 individuals; up-time was critical tour success, and, that was reflected in the support of our internal counselors applications (written entirely in-house utilizing VB.NET).
• Real-time statistics project: I was the key contributor for the entire project from start to finish. This meant supporting new hardware displays in key areas of the office as well as phone-based data presented to individuals. Using a SQL backend, ASP Classic, and VB.NET, I coded the intranet web pages to display admissions counselor stats and track these metrics; these figures were normalized in a separate repository and special Crystal Reports were authored for executive team evaluations. The success of this was key in driving accurate data, fostering knowledge and healthy competition - this was the benchmark of the universities overall business model.
• Systems support: as a small IT/development team, we were in charge of the entire code base and anything that required technology. As such, I was key in server support and integration, and, disaster recovery and protection. When we grew, so did the job … we were expected to deliver a “victory” each and every time and were held strictly accountable - whether that meant changing 10 servers to blades or simply changing our a keyboard.

Confidential

Software Engineer

Responsibilities:

• Clinical trials CHF project: I was a key member on a small clinical trials development team. My responsibilities were targeted at the specification and creation of the client front end GUI. This was written entirely in VB.NET, using legacy C++ algorithms. It was supported by a SQL 2000 backend that housed data transferred remotely by patient scale devices.
• Manufacturing support: During my tenure in the R&D department, I helped create the final system images (Ghost) that were used in manufacturing. After we lost our main manufacturing personnel, I was tasked with the role of overseeing the day-to-day activity in our manufacturing plant; this was a part-time role, and, I was expected to continue with more normal R&D functions. For me, this meant coming up to speed quickly and working long days - in the end, I was commended with an Agilent Ovation for team excellence.
• : Having come off of the heels of my manufacturing stint, I was given the task of becoming our global manufacturing trainer for new R&D initiatives. This required me to completely document the imaging process and create a program. One of the manufacturing plants to receive this, by me, was in our new plant located in Ponce, Puerto Rico.

Confidential

Technical Support

Responsibilities:

• Holter support: I was a key member of a smaller technical support team. Our goal was to support our contract customers, 24/7, with any technical or clinical problem regarding their Holter 12-lead system. It required quick response time, and occasionally required that we travel to any state within a 24 hour time period (if new hardware components were required).
• R&D Support: This was my first exposure to R&D development, on an as-needed basis, as a junior engineer. I approached the Director of R&D and expressed my interest in becoming a software engineer; I was given the chance - this meant 4 months of self-study, coding under VB and best practices. Later I was given the chance at contributing to part-time projects, which, eventually lead to a promotion from technical support to Junior Software Engineer in R&D. My first project was creating a frontend “toolbox” for our research team, to display and pan through ECG waveforms; this was written entirely in C++.