Sr. Principal Systems Engineer
Resume:
GREGORY J. ASZTALOS, MS, PMP
Dunedin, FL *****
www.linkedin.com/in/asztalos
i2bf5x@r.postjobfree.com
PROFESSIONAL SUMMARY
Accomplished Leader and Engineering Professional with over 15 years of progressive experience delivering global product and test solutions. 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 technology solutions.
ENGINEERING
Engineering Service
Requirements Analysis
Design Verification and Validation
Process Improvement and Automation
Fault Tree Analysis / Risk Mitigation
QUALITY SYSTEMS
FDA QSR / MDD / ISO9001
Lean Six Sigma Greenbelt
Maturity Models / CMM
ISO14971 Risk Management
Continuous Improvement
LEADERSHIP
Project Management / PMP
Cross-Functional Leadership
Training and Mentoring
International Team Facilitation
Outsourcing / Subcontracting
PROFESSIONAL EXPERIENCE
BAXTER HEALTHCARE, INC., Pinellas Park, FL 2006 - 2009
Senior Principal Systems Engineer/ Study Director / Supervisor
Directly accountable for requirements analysis and validation of medical devices and enterprise clinical applications for the U.S., E.U., and Asian markets. Served on leadership teams with Marketing, Clinical, Quality, Development, Regulatory and Manufacturing to enhance requirements and validation to improve the safety and efficacy of patient therapies. Led a team of eighteen engineers and technicians to analyze and enhance requirements, develop test methods and automation, generate and execute tests, and resolve issues.
• Directed over eighty studies which demonstrated product compliance to U.S. and E.U. regulations. Produced technical documents, dashboard reports, and design reviews which achieved development requirements.
• Project managed schedules, $1M budget plan, and resources which met project objectives. Modeled processes with historical and comparative data which accurately forecasted time and budget expenditures eliminating overages. Managed peak work through the effective utilization of contracted resources.
• Enabled the reduction of unnecessary steps and process points using Six Sigma DMAIC and Lean techniques which reduced test cycle and enhance quality. Ordered lab, separated material, purged cabinets, re-structured file system, and standardized procedures resulting in an efficient and effective work environment.
• Campaigned and justified HP Quality Center, a large-scale test management system resulting in a 30% IRR over three 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.
• Recruited FTEs and contractors, wrote RFQs and SOWs, trained team to use advanced test methods such as Taguchi, Pairwise arrays, and DOE statistical qualification of test methods resulting in improved test coverage and enhanced regulatory compliance.
NIELSEN MEDIA RESEARCH, INC., Oldsmar, FL 2004 - 2006
Senior Systems Quality Assurance Engineer / Team Lead
Lead responsibly for regulatory compliance testing of a business critical enterprise system required to broker $60B of advertising sales while reducing $17M of annual production costs. Directly accountable for quality, testing, initial field training, regulatory submission and audit.
• Successfully validated enterprise applications and Linux-based devices achieving regulatory compliance with a single technical submission.
• Selected and developed three engineers to generate and execute tests which produced evidence of compliance. Developed cross-functional relationships with developers, statisticians, auditors, and field organizations. Trained end-users and evaluated user needs which further enhanced product performance.
• 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. Developed an automated Perl software application to improve daily statistical analysis resulting in an 80% reduction in daily effort while improving mismatch precision 60X.
• 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.
PEROT SYSTEMS, INC., Tampa, FL 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.
• Successfully defined and validated enterprise software applications achieving client user needs and quality objectives. Architected functional and performance tests which validated software at the system, component, and unit level. Evaluated and implemented automation tools such as HP Quality Center and Parasoft JTest 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 while ensuring requirements traceability and test coverage.
• Project managed schedules and $1M budgets achieving project objectives. Analyzed system requirements using the DOORS requirements tool and facilitated development reviews using a modified Fagan format which ensured robust flow down of requirements. Wrote portions of project proposals leading to multi-million dollar contracts.
• Led a team of six engineers to generate and execute tests which produced evidence of product acceptance. Trained team in the use of requirements writing, test tools, and test methods.
SIEMENS, INC., Johnson City, TN 1986 - 1998
(Texas Instruments ISD acquired in 1991)
Senior Test Engineer, Quality Assurance Engineer and Product Engineer
Software and hardware development for over twenty regulated products including ultrasound medical devices, automotive safety devices, and industrial controls in an ISO9001 and FDA regulated manufacturing environment. Developed hardware and software for high-speed test systems. Validated and optimized processes using Six Sigma DMAIC methods. Design transferred products into manufacturing, improved yields, and product quality.
EDUCATION AND CERTIFICATION
M.S. Industrial Engineering Management, University of Tennessee, Tullahoma TN, 1990
B.S. Electrical Engineering, University of Tennessee, Knoxville TN, ABET Accredited, 1986
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
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, .Net, Microsoft Visual BASIC, Pascal, Assembler, Unix/Linux (ksh, bash)
Development Environments: Microsoft Team Foundation Server (TFS), Eclipse Statistical Tools: Minitab, WinSSD
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 QuickTestPro (QTP) and LoadRunner, IBM Rational Robot and TestManager, Parasoft JTest, CruiseControl
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