GREGORY J. ASZTALOS, MS, PMP
Dunedin, FL 34698 • 727.643.4930 • email@example.com • www.linkedin.com/in/asztalos
Accomplished Leader and Engineering Professional with over 15 years of progressive experience delivering global product and test solutions for enterprise application software and embedded devices. Proven hands-on ability to assess problems and articulate solutions that meet both business and engineering requirements. Trusted business acumen necessary for relationship building in matrix organizations. Demonstrated leadership in planning complex projects, building teams, executing, and controlling risks. Highly effective in organizations that focus on cost, quality, and delivery of medical therapies. ENGINEERING QUALITY SYSTEMS LEADERSHIP Requirements Definition and Analysis FDA QSR / MDD / ISO9001 Project Management / PMP Design Verification and Validation Lean Six Sigma Greenbelt Cross-Functional Leadership Advanced Test Tools and Techniques Maturity Models / CMM Training and Mentoring Process Improvement and Automation ISO14971 Risk Management International Team Facilitation Fault Tree Analysis / Risk Mitigation Continuous Improvement Outsourcing / Subcontracting
BAXTER HEALTHCARE, INC., PINELLAS PARK FLORIDA, 2006 - 2009 SENIOR PRINCIPAL SYSTEMS ENGINEER / STUDY DIRECTOR / SUPERVISOR Lead responsibility for requirements analysis and validation of medical devices and enterprise clinical applications for the U.S., E.U., and Asian markets. Directed formal studies which demonstrated compliance through objective evidence. Collaborated with Marketing, Clinical, Quality, Development, Regulatory and Manufacturing to enhance requirements and validation which improved the safety and efficacy of patient therapies. Accomplishments Led a team of eighteen engineers and technicians to validate an automated peritoneal medical device. Produced over eighty studies to complete the design history file required for regulatory submission. Produced technical plans and reports, dashboard reports, and design review outputs. Project managed MS Project schedules, $1M budget plan, and resources to meet business objectives. Modeled tasks with historical and comparative data which accurately forecasted time and budget expenditures to eliminate overages. Managed twelve local contractors, four Indian contractors, and two outsourced labs to effectively manage peak work. Forecasted effort, created RFQs and SOWs, screened and selected candidates, and monitored performance to delivery. Coached and motivated team which matured processes such as configuration and lab controls while improving work products such as removing requirements ambiguity and redundancy. Enabled the reduction of unnecessary steps and process points using Six Sigma DMAIC and Lean techniques which reduced test cycle and enhance quality. Campaigned and justified HP Quality Center, a large-scale test management system resulting in a 30% IRR over 3 years. Implemented an online Sharepoint which created work queues, track work products, external contractors, assets, issues, and staff schedule reducing twenty hours per week of administrative work. Introduced advanced test methods such as Taguchi, Pairwise arrays, and DOE statistical qualification of test methods resulting in improved test coverage and enhanced regulatory compliance. Wrote test procedures for the most critical risk mitigations which demonstrated compliance with objective evidence. NIELSEN MEDIA RESEARCH, INC., OLDSMAR FLORIDA, 2004 - 2006 SENIOR SYSTEMS QA ENGINEER / TEAM LEAD Lead responsibly for regulatory compliance testing of a business critical enterprise system required to broker 60B advertising sales while reducing production cost $17M per year. Directly accountable for quality, verification, initial field training, regulatory submission and audit. Accomplishments Successfully validated enterprise applications and Linux-based devices achieving regulatory compliance with a single technical submission. Selected and developed three engineers to implement and execute procedures. Evaluated and selected tools which managed requirements, manage tests, and automated manual procedures resulting in an overall 20% reduction in verification effort and a 90% reduction of report writing which met aggressive business objectives. Enhanced relationship with regulatory officials through improved project management of communication, effective status reporting, and quality of work product resulting in trusted deliverable commitments. Primary contact for regulatory officials.
Developed an automated Perl software application to improve daily statistical analysis resulting in an 80% reduction in daily effort while improving mismatch precision 60X. Developed cross-functional relationships with developers, statisticians, auditors, and field organizations. Trained endusers and evaluated user needs which further enhanced product performance.
PEROT SYSTEMS, INC., TAMPA FLORIDA, 1998 –2004 APPLICATION DEVELOPMENT SPECIALIST / TEAM LEAD Led the systems analysis and validation of enterprise application systems including a Drug Utilization Review system for the largest U.S. pharmacy chain, a HIPAA-regulated medical claims processing system for the second largest U.S. healthcare system, and a genetic bioscience system that assesses disease susceptibility and tailors more effective drug regimes for a leading genetic research firm. Accomplishments Systems analysis of requirements. Participated in proposal generation which won significant contracts. Architected functional and performance tests which validated software at the system, component, and unit level. Evaluated and implemented automation tools to achieve a 20% reduction in system verification, 80% reduction of unit test coding and execution, and 80% reduction in software build and release cycles. Integrated DOORS and Quality Center which more effectively managed traceability and test coverage. Facilitated development reviews using modified Fagan format which ensured robust flow down of requirements. Produced test plans and reports, schedules, requirements, and department procedures to achieved project objectives. SIEMENS, INC., JOHNSON CITY TENNESSEE, (SIEMENS ACQUIRES TEXAS INSTRUMENTS ISD IN 1991) 1986 – 1998 SENIOR ENGINEER Software and hardware development for over twenty regulated embedded products including ultrasound medical devices, automotive safety devices, and industrial controls in an ISO9001 and FDA regulated manufacturing environment. Accomplishments Coded embedded software for programmable logic controller (PLC) devices reducing cost per I/O channel. Developed hardware and software for high-speed test systems. Coded GUI, drivers, and logic to test system, PCB, and component specifications achieving a 50% reduction in software development and 80% reduction in maintenance support. Used Orcad and AutoCAD for capturing schematic and mechanical designs. Produced HASS/HALT tests which precipitated early life faults and improve design robustness reducing out-of-box failures to less than 1%. Design transferred, optimized, and validated processes using Six Sigma DMAIC methods reducing scrap and re-work. Facilitated quality improvement teams achieving 100% site-wide participation and 40 improvements average per person.
EDUCATION, CERTIFICATION, AND TRAINING
EDUCATION M.S. Engineering Management, University of Tennessee, Tullahoma TN, 1990 B.S. Electrical Engineering, University of Tennessee, Knoxville TN, ABET Accredited,1986 PROFESSIONAL CERTIFICATIONS Project Management Professional (PMP) Certification, Project Management Institute (PMI), 2005 - Present Past Chapter VP of Communications, VP of Programs Six Sigma Green Belt (SSGB) Certification, American Society of Quality (ASQ), 2009 - Present Professional Engineering License (PE) License, State of Tennessee, 1990 - Present COMPANY SPONSORED TRAINING Risk Management ISO14971 Training, 2009 Train the Trainer, St. Petersburg College, 2009 Management Essentials, 2008 – 2009 Finding Ambiguity in Requirements, 2008
TECHNOLOGY AND TOOLS
Requirements Management Tools: IBM Telelogic DOORS, IBM Rational RequisitePro Configuration Management and Defect Tracking Tools: Rational ClearCase/ClearQuest, Microsoft Visual SourceSafe, CVS, PVCS/Tracker Office Tools: Microsoft Project, Sharepoint, Microsoft Project, Excel, Word, Access, Outlook, PowerPoint, Visio Programming: Perl, Java, Microsoft Visual BASIC, Pascal, Assembler Development environments: Microsoft Team Foundation Server (TFS), Eclipse, Unix/Linux (ksh, bash) Operating Systems: Windows, UNIX, Linux Databases: RDBMS: Oracle, DB2, Sybase; ODBMS: Versant Test Management and Test Generation Tools: HP Quality Center / TestDirector, Allpairs Pairwise, Bender RBT Automation Tools: HP QuickTest and LoadRunner, IBM Rational Robot and TestManager, Parasoft JTest, CruiseControl Statistical Tools: Minitab, WinSSD