Greg. Asztalos, Ms, Pe, Pmp, Cissp Email & Phone Number

Florida, United States

Boston, Ma, Us

San Jose, Ca, Us

BrightInsight, Inc. builds, scales, and maintains regulated digital health products.• Led and delivered system designs of cloud, on-premise, and mobile digital health products, leading to enhanced product functionality and improved user experience.• Created comprehensive requirements, hazard analyses, FMEAs, cybersecurity analyses, and detailed designs for patient monitoring and robotic blood analyzer products, ensuring the development of high-quality, reliable solutions.• Pioneered the implementation of statistical methods to validate algorithm equivalency between cloud services and clinical studies, ensuring the accuracy and effectiveness of medical technology solutions.• Established and maintained application cybersecurity practices in accordance with AMII TIR57 and NIST, fortifying the overall security posture of digital health products.• Spearheaded the integration of cybersecurity and privacy by design into the development processes, aligning products with GDPR and HIPAA regulations, resulting in enhanced data security and regulatory compliance.• Authored five cybersecurity threat models and assessments for cloud, on-premise, and mobile apps, providing actionable insights for continuous improvement.• Developed cybersecurity risk assessment templates to identify, assess, and mitigate attack vectors, contributing to a robust risk management framework.• Conducted comprehensive training sessions on cybersecurity by design, privacy by design, and vulnerability analysis, empowering teams with essential skills and knowledge.• Facilitated client-facing security reviews of work products, resulting in consistently high satisfaction surveys and strengthened client relationships.• Coordinated, analyzed, and addressed penetration test results and CVE vulnerability scan results, ensuring the resolution of identified vulnerabilities and enhancing product security.

Fort Worth, Texas, Us

Omnicell, Inc. provides medication management automation solutions and adherence tools for healthcare systems and pharmacies worldwide.• Managed a cross-functional team comprising electrical, mechanical, software control, and reliability engineers through the successful launch of a sophisticated enterprise-connected pharmaceutical machine, achieving seamless integration and operational excellence.• Created comprehensive product requirements, risk analyses, and risk mitigation strategies, contributing to a significant increase in successful product outcomes and reduced potential risks.• Implemented IEC13485 engineering practices, leading to a notable enhancement in the quality of design outputs and ensuring compliance with industry standards.• Facilitated daily Agile/Scrumban stand-ups, fostering a collaborative work environment and achieving a remarkable 30% increase in team productivity.• Introduced advanced engineering design methods, effectively doubling the design detail and substantially improving design for manufacturability, resulting in more efficient and streamlined manufacturing processes.• Guided the team towards maturity by instilling IEC medical device practices and implementing Design for Six Sigma (DFSS) methodologies, leading to the successful implementation of three major design improvements and overall process optimization.

Consulting through MRI Network. Provided medical device consulting for product design, quality, and compliance.

Norcross, Ga, Us

(now Werfen)In Vitro Diagnostic Devices (IVD) - Robot Automated Blood AnalyzersSystems design responsibly for automated blood analyzer devices. • Conceived, planned and led R&D product development activities to achieve project goals.• Applied technical expertise in materials, mechanisms, fluidics and mechanics to lead efforts in test method development, implementation and validation for medical device/systems. • Responsible for assessing design feasibility and verifying product functionality and/or confirm product capabilities.• Designed experiments using DOE methodology and analyze the test results using statistical tools. Interpret the results correctly and provide feedback effectively for design improvements.• Participated in the design of new products and design improvements to existing products.• Engaged OEMs to provide technical oversight and guidance on the evolution of the design.

Norcross, Ga, Us

Systems design responsibly for automated blood analyzer devices.

Chicago, Il, Us

(now Baxter International, Inc.)Lead systems design responsibly for advanced wound care therapy devices and medical beds in post-acute, extended, and home care environments. I delivered the following on multiple projects.• Concept Engineering: user interviews, language processing, customer needs definition• Systems Architecture: context, functional and physical breakdown, platform design, options analyses• Functional Requirements and Use Cases: user need translation, use and foreseeable misuse scenarios• Design Requirements: system, subsystem, and interface design inputs• Risk Management: plans, risk analyses and control, FMEAs, and reports• Reliability: plans, Weibull and MTBF analyses, reports• Recruited and supervised internal and external resources: full time, contractors, regulatory consultants• Oversaw development and testing• Led CAPA investigations, action plans, and effectiveness verification• Internal SME for Product Architecture, Risk Management, and Use Cases

Chicago, Il, Us

Tampa, Fl, Us

Deerfield, Illinois, Us

Lead systems and validation engineer directly accountable for requirements analyses and validation of dialysis medical devices and clinical software applications.• Reviewed and enhanced systems architectures for next generation product• Performed fault tree analyses improving the safety of next generation product• Supervised validation engineers, analyzed requirements, developed test methods and automation, generated and executed tests, wrote reports, and resolved product issues. • Project managed two labs, schedules, $1M budget plan, materials, and technicians. • Recruited FTEs and contractors, wrote RFQs and SOWs, trained team to use advanced test methods such as Taguchi, Pairwise arrays, and measurement system analyses resulting in improved test coverage and enhanced regulatory compliance.

New York, Ny, Us

As Senior Systems QA Engineer, I led 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 end-users and evaluated user needs which further enhanced product performance.

New York, Ny, Us

Round Rock, Texas, Us

(now Dell Technologies)As Application Development Specialist, I 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.

Munich, De

(formally Texas Instruments ISD)As Senior Engineer, I led 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.

Munich, De

Munich, De

Ms, Engineering Management

Bs, Electrical Engineering