SUMMARY

7+ years of experience in S/W Verification & Validation (V&V), Requirements Engineering and Quality Assurance in FDA regulated medical device, life sciences and healthcare industries. More than 20 projects as Quality Assurance and V&V lead. Extensive hands on experience with Enterprise IS (Information Systems) Quality Systems, Web Applications and critical PC/Embedded systems.

PROFESSIONAL EXPERIENCE

Confidential, Natick, MA
Software Quality Assurance Engineer II May 2009- Aug 2010

• Established and maintained standards for Software Quality policy, processes and procedures which meet BSC and external regulatory requirements.
• Collaborated with the BSC system implementation teams to ensure regulatory / 21 CFR Part 11 compliance
• Identified process gaps and implemented corrective actions as Quality lead on large-scale Enterprise Quality Systems
• Provided guidance to IS (Information Systems) teams on V&V, Project and Configuration Management strategy/processes
• Managed multiple simultaneous validation/change control activities and participated in CAPA investigations

Sample Projects:

• Primary Quality Approver for System Development Tools (IBM ClearQuest, Clearcase, RequisitePro) that automated BSC IS System Change Request process.
• Accountable for quality reviews and approval of all applicable quality documents needed to maintain validated state
• Analyzed trends in quality issues and provided recommendations for corrective action
• Performed methodical ‘bidirectional’ trace analysis to ensure completeness of Requirements Traceability Matrix
• Provided independent feedback on unit and system testing deliverables and helped define scope for regression tests
• Independent Reviewer and quality sign-off for select BSC SAP units including the NeuroModulation business integration effort
• Collaborated with IS team on Project /Test/Implementation/Training plans and reviewed execution milestones
• Performed Quality Control reviews to ensure consistency of Requirements, Design and applicable Test documents.
• Served as SME on selection of validation activity based on risk and complexity of software change
• Assisted with Production Support plan and served as Quality representative for Go-No Go decisions
• Primary SQA representative for electronic system that tracks/store master regulatory submission status
• Provided input on disposition/priority of change requests as Quality representative on the Change Control Board
• Identified applicable validation methodology for software based on Intended Use Assessment
• Simplified process used to maintain Software Validation Report and Design History Files

Confidential,Ann Arbor, MI
Verification and Validation Lead Dec2005-Nov 2008

• Ensured compliance with ISO and FDA quality system regulation and software practices
• Performed quality control by providing support to project teams in software requirements definition, architecture, design, implementation and testing phases of the Software Development Life Cycle
• Planned, implemented and executed system, unit and integration test strategies and performed intended use validation on third party tools
• Supported software risk/hazard analysis using Fault Tree Analysis
• Held responsibility for sign off on all V&V deliverables, software release and configuration management
• Managed multiple projects with short deadlines and communicated progress of projects to clients and upper management

Sample Projects

• Assisted in obtaining FDA approval for a micro-array based molecular diagnostic system focused on cancer care

The Java based product was a complex web based analytics tool that used a micro array to aid in the diagnosis of the origin of uncertain tumors

• Worked with the client in defining software system and subsystem interface requirements.
• Helped identify corner test cases and scenarios to ensure that the results of the software analysis matched clinical results.
• Developed Requirements Traceability Matrix using DOORS to prove that all requirements were tested
• Analyzed and logged bugs using Bugzilla to generate reports and track software quality metrics
• Enforced strict source code version control through use of WinCVS to maintain integrity of testing results
• Led team of 8 in Verification effort for a Remote ECG Data Management system for Confidential,

The Remote ECG Data Management System consisted of ECG data/device information transfer from patient implantable loop recorder to clinicians. XML data transfer was over PC Web/Windows services(C#, IIS) communicating with the device over SSL. Patient/Device/ECG Data Management was through an ASP.NET Web Interface with MS SQLServer Management Express as backend

• Defined requirements by working with the client and software development team
• Identified key design and database inconsistencies by participating in software design and architecture reviews
• Designed the testing framework and developed all test plans/scenarios for GUI, Database, Usability and Interface testing
• Used Resource Standard Metrics (RSM) source code complexity tool to perform code analysis and determine software integrity level
• Managed and trained V&V team to drive product development from design to deployment
• Verification and Validation lead for Reagent based testing GUI application, for a company that develops and markets molecular diagnostic reagents for a wide variety of DNA and RNA analysis based on its proprietary technology.

The Assay Panel Manager (APM) was a Java based software product used to select, analyze and report on reagent based testing of clinical samples. The APM supported multiple assays with decisions as to the presence, absence, or potential presence of a biological agent.

• Led project V&V planning and execution, anomaly tracking and regression testing
• Reverse engineered requirements, architecture and design from source code to enable product testing
• Implemented testing framework to test software on multiple platforms for US and European configurations
• Project Manager and Validation lead for a Pressure based therapy system for a leading pain therapy product manufacturing company

The Pressure based therapeutic system used a proprietary Sensor technology to inflate and deflate a mattress and provide optimal floatation therapy. This embedded system was controlled by 80C32 and PIC micro controllers and the control unit firmware was PIC/80C32 assembly and 80C32 C

• Managed a team of 4 and was responsible for project budget/schedule, technical and V&V deliverables
• Developed software/firmware requirements from customer product specifications and manuals
• Performed traceability using DOORS to ensure that all Risk Analysis items were mitigated by Blackbox or Whitebox tests
• Conducted structural unit testing of PIC ASM and 80C32 code using MPLAB IDE and 80C51compiler

Confidential,AnnArbor, MI
Systems EngineerJun2003-Nov 2005

Developed and executed test procedures for Blackbox/Whitebox testing

• Participated in formal and informal code and technical document reviews
• Developed Software Design and architecture specifications and coded Serial communications/Web/Database applications
• Performed intended use validation of Parasoft automated unit test tool and DOORS Requirements tool

TECHNICAL SKILLS

Languages: C, C++, Java, C#, VB, PIC Assembly
Operating System: UNIX, Linux, Windows, Windows CE
Databases: Oracle, MS SQL Server
Development Environment: Visual Studio, Eclipse IDE, Microchip MPLAB, ICE2000, 80C51 C compiler
Web Based Technologies VB.NET, ASP.NET, HTML, XML, VB, SOAP, Apache, IIS, Web Services, Windows Services.
Other Tools: RSM, Parasoft C++ Test/ Jtest, Bugzilla, DOORS, ReqPro, WinCVS, LookRS232, MS Project, Visio, Doxygen
Protocols: RS-232, ASTM, HTTP/HTTPS

EDUCATION

MS, Electrical and Computer Engineering
Bachelors, Electrical and Electronics Engineering