TECHNICAL SKILLS:

V&V Testing: Black box, white box, functional, unit, iterative, integration, system, regression, performance, stress, UAT

Quality/Regulatory and Work Experience: QSR, FDA 21 CFR Part 11, CFR 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601, cGMP, GAMP 4, DMR, CAPAs, NCRs, DMR, DFMEcA, GxP

Methodologies/Processes: RUP, Agile (SCRUM, SPRINTS, XP), SEI, CMM, CMMI

Programming/Scripting Languages: C/C++, Assembly, JAVA, SQL, VB, Perl, ABEL - HDL, Korn Shell, LabVIEW, MATLAB, Turing, JCL, COBOL II, JCL/CLIST, FORTRAN

Software: MS-Office 2010, SVN (windows & Linux), MS-TFS, IBM DOORS v9.2/RPE v1.1.1, Citrix, ClearQuest, ClearCase, Rational Robot, Rational Test Manager, WinCvs, Wiki, eMatrix, Documentum, PDM, Visual Studio, JIRA

Hardware: Motorola DSP560001, IBM compatible, SUN Workstation, IBM mainframe, DEC, VAX/VMS, electronic boards blue print readings/reviews/audits (GD&T)

Environment: UNIX, Linux, Windows Vista, Windows XP,Windows 7, OS/2, Windows NT 4.0, Windows 2000, DOS, TSO/ISPF

Commercialized Tools: QTP, WinRunner, LoadRunner, Test Complete, QA Director, QA Run, Test Director, HP Quality Center 9.2, SeaPine ALM, PLM Agile, LiveLink, PowerHelp

PROFESSIONAL EXPERIENCE:

Confidential - Providence, RI

Design Quality Test Engineer / Validation Developer II

Responsibilities:

• Design Quality Assurance work for teh Atrium Medical
• Part of Remediation effort team on Drain legacy product
• Review and manage process control, Risk Management, DFMEcA, Gap Analysis, SOPs, Traceability Matrices, Sample Sizing, CAPAs, NCRs, etc.
• Review DIRs, IQ/OQ/PQ, TMV, SRS, PS, V&V Master Test Plan, Protocols and Reports
• Work on eDrain new medical device product requirements creation and review
• Perform V&V Engineering tasks on DDS (Digital Dosage System) Class II device project for Sanofi

Confidential - Framingham, MA

Principal QA Software/Hardware Electrical Engineer

Responsibilities:

• Worked on biomedical multiple class III VAD devices (i.e. PAL0, PAL1)
• Reviewed and provided input on DIR/SRS/PS documents for multiple invasive Devices
• Helped manage process control, RM, DFMEcA, Gap Analysis, SOPs, DTM, CAPAs, NCRs
• Reviewed and provided comments on Test Protocols and Test Reports for multiple projects
• Managed and audited work by Third Party External Vendors (Foliage)
• Helped wif Process Improvement efforts in teh QA department
• Created products software and hardware issues and defects using Seapine ALM System
• Trained and mentored new contractors (Foliage)

Confidential - Westerly, RI

Quality Assurance and Regulatory Affairs (QARA) Specialist

Responsibilities:

• Worked mainly wif Agfa’s Services Department to ensure quality customer service
• Wrote and conducted sessions on Post Market Design Control for Service teams
• Reviewed and helped wif writing Clinical and Technical Quality Procedures by Service teams
• Performed internal audit on Agfa’s Service Department
• Reviewed requirement documents, manual verification and validation test cases and test reports
• Monitored MDRs, and worked wif PD team on NCR and CAPA entries.
• Used LiveLink system for document control, PowerHelp system for customers requirement entries

Confidential . - Waltham MA

Principal SW and HW Quality Engineer

Responsibilities:

• Managed teh SW & HW Validation procedures and processes wifin teh QMS
• Worked on Non Conformity Reports, CAPAs and brought to resolution
• Written and modified existing SOPs
• Wrote verification and validation master test plans and manual test cases
• Wrote and executed manual testing of teh Avedro KXL and Vedera Medical devices
• Analyzed equipment requirements and designs and developed product risk assessment
• Provided input designs to product design team on requirement specs
• Made risk-based decisions and balanced business and compliance issues

Confidential . - Framingham MA

Principal HW and SW V&V Engineer

Responsibilities:

• Performed V&V efforts on newly developed Miniaturized Ventricular Assist Device (MVAD)
• Wrote, reviewed and executed System level test cases for teh MVAD product
• Wrote, reviewed and executed test cases on MVAD Device Controller Embedded Software Code
• Self-trained and daily used teh SeaPine ALM System, and Agile PLM
• Participated in teh review process of Design Input Requirements, SRS and Master V&V Plan
• Monitored and audited work by Third Party External Vendors (from USA, India)
• Contributed in building V&V process improvement and standardizations
• Contributed ideas in writing SOP for OTS software applications
• Mentored peers upon request

Confidential - Farmington Hills MI

Sr. Test Engineer

Responsibilities:

• Coordinated software system testing and production implementation verification wif Confidential IT staff and customer testers
• Analyzed requirements, developed and executed test cases for facilitation of Interface Testing, Integration Testing, User Validation Testing, Charge System Testing and performed other project related activities
• Attended requirements reviews, support development of Test Plans, create various testing documentation, including test metrics, defect and test summary reports
• Wrote and executed Load Runner scripts
• Created documents control system using Quickbase database
• Helped improve software testing process

Confidential - Chicago, IL

Sr. Software Systems Engineer Contractor

Responsibilities:

• Led system testing of embedded software modules for teh new Map Positioning Engine
• Used Oracle 10g and SQL/SQLPlus to test correctness of Spline (NURBS) data output
• Used Quality Center to write, review and execute tests
• Used Control-M tool to set, configure and execute all application modules
• Managed outsourced project tasks to external company in Europe
• Modified UNIX ksh scripts to perform daily tasks
• Practiced Agile process (i.e. SCRUM, SPRINTS, XP)
• Created System Test Traceability Matrices and Test Reports
• Help improve teh current System Testing process

Confidential - Ann Arbor, MI

Software Validation Engineer

Responsibilities:

• Lead cross-functional teams through teh validation efforts of multiple application systems including teh JDE ERP System
• Participated in teh development of new QSP (Quality System Procedure) for non-product software
• Helped organize, create and author all teh Work Instruction Forms (WIFs) for teh new QSP
• Authored validation plans, validation protocols and validation test scripts for various AUTs
• Executed test scripts, logged defects and followed them to resolution
• Researched teh eMatrix System procedures to identify and validate many Excel files
• Work wif various department as QA and Validation subject matter expert based on teh new QSP
• Helped create a controlled Excel database index file wif audit trail log
• Assumed hands-on leadership role wif teh R&D department for teh validation of DOORS v9.2/ RPE v1.1.1
• Performed internal audit on all systems (JDE, PRMS, FS400, SMPlus, CNT) used for Recall activities.
• Performed gap analysis on Quantum Test Stands Validation efforts.

Confidential - Cleveland, OH

Sr. Software Test Engineer

Responsibilities:

• Installed, configured, and integrated various modules and components of PACS system.
• Wrote validation plans, test protocols and test scripts for teh new PACS system.
• Performed unit/module, functional, regression, integration, and system testing of Radiology PACS software system running on teh Windows platform.
• Set up test lab environment including OS installation, network and domains configuration, ghosting systems images.
• Performed verification and validation on DICOM, HL7 based medical image viewing software systems.
• Participated in requirement discussion, analysis, design discussions
• Daily use of ClearCase, and HP Winrunner automated tool.
• Use HP Quality Center 9.2 as teh main tool for writing and executing test procedures, traceability and reports creation.

Confidential . - Neenah, WI & Milwaukee, WI

Sr. Verification and Validation Engineer

Responsibilities:

• Worked on Diagnostic Cardiology (DCAR) MUSE applications, DCAR Carts, and Image Vault DICOM Image Processing PACS product.
• Tested HL7 communication protocol between MUSE applications, DCAR Carts
• Tested computerized data acquisition systems for DCAR in both standalone and networked environment.
• Wrote V&V test plans and test scripts using HP QC 9.2
• Created defect reports, performed regression tests, created traceability matrices and daily testing reports using QC 9.2
• Set up test lab environment including OS installation, network and domains configuration, ghosting systems images.
• Performed heavy FDA-compliant documentation following new process documents.
• Worked on Firmware/Software validation for teh St. Jude Medical Merlin Basic at Home System
• Daily TCON communication wif Third Party External Vendor (from Sweden)
• Wrote FDA and ISO regulated COTSS validation plans, data sheets, and procedures
• Implemented and executed tests on Windows and Linux platforms.
• Used Rational Suite tools to perform day-to-day activities.
• Used Rational ClearQuest for tracking defects and changes to functionality of AUT
• Automated functional tests using Rational Robot.
• Used teh RUP development methodology process for teh testing and documentations.

Confidential, Shoreview, MN

Sr. Verification and Validation Engineer / Sr. QA Engineer

Responsibilities:

• Wrote, and executed tests for spreadsheet applications and Java Testing tools.
• Trained on CAPA, FMEA, SOPs, HIPAA, and GDP.
• Ran tests in teh CRM lab environment for recalled implantable devices.
• Reviewed manufacturing documents to ensure SOPs and FDA regulations were met.
• Monitored developers and testers so CAPA and FMEA methodologies were adhered to.
• Wrote, reviewed software FS/IQ/OQ/PQ documents as per QSR
• Involved in execution of test scripts on teh manufacturing lines.
• Reviewed and redlined Software Configuration Specification documents (SCS)
• Regularly met wif various teams to monitor schedules and deadlines.
• Involved in daily SCRUM meetings as part of teh agile process.

Confidential, Fridley, MN

Sr. Software Verification and Validation Test Engineer

Responsibilities:

• Directed and led 7 developers and 2 VT engineers to complete a highly visible project.
• Exercised agile process and led SCRUM meetings.
• Performed manual and automated V&V testing on implantable ICD devices.
• Designed, developed and executed test plans, and test procedures for invasive devices
• Performed regression, stress, black box, white box, and performance testing.
• Participated in peer reviews of test plans, and test procedures.
• Developed C programs, GTS and FGTS automated scripts.
• Used WinRunner and LoadRunner scripting tools to automated test scripts.
• Developed test tools using VB and C/C++.
• Performed database backend testing using SQL Plus.
• Supported teh Patient Management group wif data creation for their development and testing.
• Used Labview to program ICD breadboards as needed.
• Utilized CVS, SCR system, and Documentum for documentations and software control

Confidential, Minneapolis, MN & Colorado Springs, CO

Sr. Test Engineer

Responsibilities:

• Worked on a web-based, voice over data software system project
• Wrote and executing test plans and test procedures for teh backend and front-end systems
• Maintained and administered teh backend ORACLE 8.0 database system
• Wrote manual and automated test scripts using Mercury Quick Test Pro (QTP)
• Tested teh functionality and interface of a third-party vendor product wif Gelco’s systems
• Created and executed test plans and procedures for LEC switches, traffic system loads and MCI network elements on UNIX, mainframe and Windows environment
• Regularly worked wif JCL, REXX and CLIST for execution of tests
• Developed midrange (UNIX) and Mainframe test tools using C language
• Performed verification on UNIX midrange traffic system (TFEC)
• Used Mercury WinRunner to write TSL automated scripts for Windows-based applications
• Assisted three different groups wif several projects
• Used teh SEI (CMM/CMMI), and RUP methodologies
• Tested teh migration of teh System One application from OS/2 to Windows NT4.0
• Created and reviewed test procedures using Lotus Notes 4.6