PROFESSIONAL SUMMARY:

• 20+ years of experience in the field of Medical Device Validation/Verification, CSV, DFMEA, Risk Analysis, QA/V&V/IV&V for Embedded RTOS Systems, in the Pharmaceuticals, Healthcare, Medical Device, DOD, and Financials industries
• 20+ year’s experience CSV validating applications in an Confidential regulated environment
• 20+ years’ experience working CSV with ISO13485, ISO14971, ISO 9000 series, 820.30 & 21 CFR Part 11 regulations
• Includes full Software/System Development Life Cycle (Agile - RUP, iterative, spiral, waterfall and incremental), Software Engineering, CSV, SOA, RUP, UML, OOD/OOA, Enterprise/Web/Distributed Systems, Systems Engineering, Work Flow Validation, Requirements Gathering/Analysis/Design, Unit Level Testing, IQ, OQ, PQ, Software Integration, 510K Submissions, Pre-clinical software, Independent Verification and Validation, Quality Assurance and experience with component-based service oriented architectures.

TECHNICAL SKILLS:

• ReqPro & DOORs
• RTM
• HP Quality Center/ALM-11
• Visio
• Pilgrim/Trackwise
• ISO 14971
• ISO 13485
• ISO/IEC 62304
• Rational Rose/RT/XDE
• Rational Test Manager
• Artisan SW Designer
• SQA Robot J
• Waterfall SDLC
• IBM Midrange
• VAX/VMS
• Clearcase/Clearquest
• C / C++/Java/J2EE
• ADA
• Allen Bradley & Honeywell PLCs and SCADA
• RS Logic Rockwell for PLCs
• Hibernate
• OOA/OOD
• UML/OCL
• Complaints Handling
• CAPA
• SDLC
• Automated Test Scripts
• GAMP 5
• Design Patterns
• 21 CFR Part 11, 211820
• ARINC-429/629/APEX
• IQ/OQ/PQ
• Design Validation
• Reliability
• HL 7 Protocol
• HIPPA Compliance
• Protocol Analyzers
• Network Analyzers
• Waveform Generators
• Automatic Fault
• Insertion
• ClinTrial
• Clinical Database Validation
• Gap Analysis
• Documentum
• Rational Enterprise
• Analyst Studio
• Requirements Analysis
• JAR/JAD Sessions
• SAS 7.0
• Xrunner
• WinRunner
• LoadRunner
• TQM
• ISO9000 SEI/CMM/CMMI procedures
• Embedded Systems
• IT/API White-Black
• Box Level Testing
• UNIX / AIX / NT
• TCP/IP
• DO178B
• JUNIT
• Seque/Silk

PROFESSIONAL EXPERIENCE:

Confidential, Wauwatosa, WI

Verification Engineer Lead

Responsibilities:

• Verification of Confidential Cardiology Products, Class II Medical Device both Dry Run and Formal Verification Testing.
• Verification of FFR, Waveform Generation Unit, ITU, Holding area DASH, German-Real-time Risk Analysis Mitigation DVP-DVR, German Barcode Testing and mitigation, Mac Lab and Cardiolab Dry Run testing and mitigation.
• Authored Test Requirements, Test Strategy, Test Plan, Test Cases, Test Procedures, Unit Level Test Strategy & reports for 510K Submission and usability.
• Provided regulatory compliance guidance for software applications.
• Lead, performed, consulted & provided leadership for the QSR System/Record implementation.
• Wrote and executed Validation Plan, URS, FRS, RTMs (Requirements Trace Matrix), IQs, OQs and PQs and implemented them into HP Quality Center for Manual, as well as, Automated Testing.
• Generated Formal Equipment Configuration Trackers for the German and French standalone systems, as well as, the English standalone systems
• Setup hardware, cabling, software installs on standalone English, German and French systems and test harnesses for IEB, Acquisition system, as well as, the review systems.
• Mentored new hires on dry run testing and policies, as well as, procedures when needed.
• SPR Anomaly & Deviation Summary Reports, DVPs-DVRs & Test Reports for Dry Run and Formal Testing of Confidential applications.
• All documentation, testing and evaluation pursuant to IEEE & ISO Standards, IEC13485, ISO14971, ISO62304, 21 CFR Part 820.30, as well as, Confidential 21 CFR Part 11, 211 & 820.11. Utilized: DOORs, DOORs eTest, Clearquest, Myworkshop, ALM 11 HPQC and Clear case

Confidential, Lake County, Illinois

Software Consultant

Responsibilities:

• Review and approved Functional Requirement documents (FRS) in HP Quality Center (QC) - ALM 11 as per Validation Policy and SOP's
• Review and approve Validation Test plans (VTP) in HP Quality Center (QC) ALM 11 within following Quality Assurance Library guidelines
• Review and approve Process description document (PDD) in Solution manager (SAP) system.
• Review and approve Functional design document (FDS) in Solution manager (SAP) system
• Work with Release management team for authoring Incident reports, review and approve on timely basis
• Author System certification and present it to review board.
• Peer review and approve Validation Change request documents (VCR s) in GIS Packet
• Tracker Application (PTA)
• Write Traceability matrix report, Test Summary reports and present it to review board..
• Conduct test review meetings with testers and provide review comments.
• Proactively work with application leads/analysts to identify changes coming in for the forthcoming releases
• Work closely with development team, business analysts to perform testing activities as per schedules
• Perform Test case coverage metrics and reporting to the QA Management
• Conduct status meetings with QA teams, BSA s and Developers

Confidential, Waukesha, Wisconsin

Software Consultant

Responsibilities:

• Authored Test Requirements, Test Strategy, Test Plan, Test Cases, Test Procedures, Unit Level Test Strategy & reports for 510K Submission for Revolution RECON Team CT SCAN.
• Provided regulatory compliance guidance for software applications.
• Lead, performed, consulted & provided leadership for the QSR System/Record implementation.
• Wrote and executed Validation Plan, URS, FRS, RTMs (Requirements Trace Matrix), IQs, OQs and PQs and implemented them into HP Quality Center for Manual, as well as, Automated Testing.
• Performed Requirements & Design Analysis, Feasibility Study, in order to, understand the user needs for Revolution
• Authored Software DFMEA for all software levels (code level up to Services Oriented Architecture Level) for all services, as well as, interfaces.
• Performed informal and formal Risk Assessment from DFMEA for Obelus and RECON and placed in Reliasoft’s xFMEA Toolset for conversion into different reports and reuse.
• Facilitated Test Readiness discussion sessions with users, analyzed information from users, survey Confidential /customer responses, and user behavior on internal and Confidential web sites
• Developed system test requirements based on user and functional needs.

Confidential, Maple Grove, MN

Software Consultant

Responsibilities:

• Technical Project Lead Software System Pacemaker Test & Process Analysis, Software Engineering: Oxygen Level “Pacemakers” for the heart (65CO2 & 6804 up C/Assembly). Authored Test Requirements, Test Strategy, Test Plan, Test Cases, Test Procedures, Unit Level Test Strategy & reports for 510K Submission..
• Served as a Team Member/Technical Lead of the Retrospective Evaluation Team for the retrospective evaluation of the Oxygen Level Sensors
• · Provided regulatory compliance guidance for software applications.
• Lead, performed, consulted & provided leadership for the QSR System/Record implementation.
• Wrote and executed Validation Plan, URS, FRS, RTMs (Requirements Trace Matrix), IQs, OQs and PQs for packaging/assembly lines, which included validation of PLC’s, Vision Systems, Operating Systems/Networks, COTS software packages, Micro Controllers, Configurable software packages (SCADA, LAS and MRP), as well as Custom Built Systems.
• Performed Requirements Analysis, in order to, understand the user needs for Oxygen Level Sensors
• Facilitated Test Readiness discussion sessions with users, analyzed information from users, survey Confidential /customer responses, and user behavior on internal and Confidential web sites
• Developed system test requirements based on user and functional needs.
• Supported the test architecture for web-based “telemetry applications” for the Pacemakers for physician monitoring.

Confidential, Lake Zurich, Illinois

Medical Device Validation Consultant

Responsibilities:

• Responsible for Project Plan(s) and setting up tasking, tracking & reporting. Cygnet is a Class II Medical RTOS device extensively used by the America Red Cross around the world & ClinTrial. It is part of the Blood Donor Equipment with a series of pneumatics, hydraulics & controllers that extract blood from a patient and separate it into Saline, Anticoagulants and plasma, as well as, placing a portion of that back into the patient in real time.
• Phase forward is a leading provider of integrated data collection and data management solutions for clinical trials and drug safety using ClinTrial.
• ClinTrial™ software product is a comprehensive, regulatory compliant, process workflow clinical data management system used to collect, manage and review clinical data that interfaces with Pilgrim Trackwise software. The ClinTrial™ product was implemented at Fenwal Inc, in order to; enhance data quality for paper-based trials, to integrate hybrid trials and to gain increased real-time data access for a variety of clinical scenarios. The use of this software was a new implementation for Fenwal Inc which back-ends into Oracle 9I.
• Authored the Cygnet Class II device: Project Plan, Validation Plan(s), IQ, OQ & PQ Test Protocols, URS, FS, Design Spec, Design Validation Protocols, Trace Matrices, Risk Assessment, Change Control Policy, QRA/21 CFR Part 11 Assessment, Supplier Quality Audit Compliance paperwork, Test Scripts for IQ/OQ/PQ, along with unit and grey box level testing, the Validation Closure Reports portion of the project and Final Reports.
• Utilized ReqPro, DOORs, Quality Center Test Director, ISO 13485, McCabe Battleship, Seque/Silk, Borland Java Debuggers, Borland Java Enterprise Test Suite, JUNIT, Borland Enterprise Compilers, Documentum, Rational Rose, Rose RT(Java), Oracle 9I & PL/SQL, Requisite Pro, Quality Center Test Director and DOORs for full traceability from top to bottom & vice versus.

Confidential, LA

Medical Device Validation Consultant

Responsibilities:

• Served as a Team Member/Technical Lead of the Retrospective Evaluation Team for the retrospective evaluation of the Oxygen Level Sensors
• Wrote and executed URS, FRS, RTMs, IQs, OQs and PQs for packaging/assembly lines , which included validation of PLC’s, Vision Systems, Operating Systems/Networks, COTS software packages, Micro Controllers, Configurable software packages (SCADA, LAS and MRP), as well as Custom Built Systems.
• Performed Requirements Analysis, in order to, understand the user needs for Oxygen Level Sensors
• Facilitated Test Readiness discussion sessions with users, analyzed information from users, survey Confidential /customer responses, and user behavior on internal and Confidential web sites
• Developed system test requirements based on user and functional needs.
• Supported the test architecture for web-based “telemetry applications” for the Pacemakers for physician monitoring.
• Validated and verified the satisfaction of requirements for system design.
• As Validation Leader: Wrote and executed QRA, 21 CFR Part 11 Assessment, Supplier Quality Audit, Risk Management Plan, Change Control Plan, URS, FRS, DS’s, RTMs, Design Validation Protocols, Issue Tracking, Training Material, Updated SOPs, Updated Work Instructions, Anomaly & Deviation Summary Reports, IQs, OQs, PQs & Validation Reports for packaging lines, which included validation of Oxygen Level Pacemakers with 8 bit micro-controllers.

Confidential, Chicago, Illinois

Medical Device Validation Consultant

Responsibilities:

• Technical Validation Lead Quality & Regulatory Architect Consultant (21 CFR Part 11)
• Functioned as Validation Lead/Manager V&V Test System/Process Analyst for a Pre-clinical and Clinical Radiology Imaging (Class II Medical Device RTOS System) Software and hardware project. Performed Software QA Verification Architecture, Process Work Flows
• Requirements/Analysis, Software Process Design, Test Use Case Requirements Gathering, Use Case, Collaboration, and Sequence Diagrams, State Diagrams, Class Diagrams, SAD (Software Architecture Document), RTM, FRS, URS, Software, Hardware and Firmware Test Analysis/Design pursuant to IEC 62304.
• Conducted functional & unit level testing, and handled Test Architecture on Harmony Radiology Instrument (Class II Medical Device) at all levels throughout the Software Development Life Cycle per Confidential Standards component service-based structured methodology for HL7 interface.
• As Validation Leader: Wrote and executed QRA, 21 CFR Part 11 Assessment, Supplier Quality Audit, Risk Management Plan, Change Control Plan, URS, FRS, DS’s, RTMs, Design Validation Protocols, Issue Tracking, Training Material, Updated SOPs, Updated Work Instructions, Anomaly & Deviation Summary Reports, IQs, OQs, PQs & Validation Reports on Allen Bradley PLCs, Honeywell SCADA in Manufacturing environment with Rockwell Automation RS Logix Ladder Logic
• Validated Software packages, Micro Controllers, Configurable software packages (SCADA, LAS and MRP), as well as Custom Built Systems.
• Performed Software QA Requirements & Process Work Flow Analysis to understand user needs for US Radiological data and Toxicology/LAR/Pharmacology n-tier systems.
• Facilitated the development of Business and System Use & Unit Level Test Cases
• Performed QA systems analysis design and Test architecture activities
• Produced Domain Models, Class Models, Activity Diagrams, Sequence Diagrams, State Diagrams and key process flows
• Utilized Rational Unified Process (RUP) and developed business test process flows, system flows, and validated Object-Oriented design methodology and verified/validated the same.
• Determined & re-engineered, ideal business work flow processes/process validation as well.
• Conducted Initial GAP analysis with the current systems.
• Validated the Object-Oriented design and development in Java (Jbuilder Enterprise 9), and coded all method constructs and all classes/objects/J2EE Enterprise, session, entity beans
• Used front end Servlets and JSPs with Tomcat
• Reverse engineered code, developed naming conventions and performed data analysis
• Led and developed QA System Architecture documentation (SAD to RUP-UML-Rational Automated Test Tools)
• Facilitated JAD/JAR discussion sessions with users, and analyzed information from users, including oral and written feedback, survey Confidential /customer responses, and reviewed user behavior on internal and Confidential web sites
• Developed Automated QA Test Plan & QA Objectives/Requirements and maintained traceability throughout all documentation by using DOORs, Requisite Pro, Rational Rose, Rational Rose RT, Oracle 9I & PL/SQL and Clearcase
• Automated testing was completed using Test Director, WinRunner, and LoadRunner.