Tal Epshtein

Experience

• 

  Elbit Systems Ltd

  May 2012 - Jan 2020

  Sr. Verification and Validation (V&V) Engineer, Verification and Validation Lead

  • Executing projects involving the verification and validation, and regression testing activities for certification of real-time embedded locomotive control systems according to DO-178C, Software Considerations in Airborne Systems and Equipment Certification. Specialized in testing of Aviation projects over dedicated Real Time hardware in flight control computers and aviation helmets.• Evaluate design documentation for expected functionality.• Develop formal documentation throughout the project life-cycle and report in compliance with the design review management and action tracking system – STP, STD and STR.• Identify V&V and regression testing requirements for each functional subsystem customer.• Execute validation and regression tests using client Hardware-In-The-Loop (HIL) simulators and/or actual Locomotive: - Simulator Hardware & Software - Configuration management: DOORS, QC-ALM and TFS. • Identify/Report defects, perform root cause analysis and recommend necessary design changes required to complete successful validation.• Proficient in test strategy of developing and managing a verification and validation process in Agile life cycle.• Develop, release and support the automated test effort by writing/running test scripts.• Interface with peer groups and develop continuous improvements in the overall test process.• Strong exposure to Generation of Use cases &/ Test cases and Preparation of defect report.• Issue/Defect resolution, Good troubleshooting skills, Code/Design review, Baseline Integration.• Communicate System Engineering related issues to different System Engineering teams.• Development environment setup, review highly technical test procedures, provides feedback on test procedures for clarification.• Follow test procedures and execute validation testing, step by step, seeking clarification for any uncertainty and giving accurate results with high integrity. Show less

• 

  Medtronic

  Jan 2020 - now

  As a Senior Design Quality Engineer, I take an active part in the development of the Medtronic Yokneam site products, by ensuring that design control is properly maintained and executed, monitoring changes to current product designs, follow the corresponding requirements set forth by local procedures, regulatory authorities and notified bodies.• Develop and manage the process that establishes and maintains quality assurance and regulatory programs, policies, processes, procedures and controls to ensure that the performance and quality of products conform to established standards and agency guidelines.• Mentor and coach, Design quality assurance, R&D in Regulatory and Industry best practices in Design and Development related procedures.• Review and approve product Verification and Validation strategy Review and approve design documents and processes in accordance with Design Controls standards and company's policies.• Lead process improvement projects and conduct training with Quality Operation.• Support during external inspections and participating in the management of external inspections as required.• Prepare management reports depicting trends and useful data for management review purposes.• Reviews Design Change Process.• Support RFAI and interactions with worldwide competent authorities & notified bodies.• Drive QMS & product continuous improvement through IIA process, CAPA process, CAPA investigations, CAPA & compliance audit trending of quality data streams.• Evaluate corrective and preventing action responses to the assessment findings for adequacy, including root cause and timeliness. Elevate issues to management, as appropriate.FDA Quality System Regulation 21CFR 820, 21CFR Part11, ISO13485, ISO14971, and the Medical Device Directive MDD/MDR.Familiar with IEC 60601 and product-specific industry standards. Show less

  • Senior Design Quality Engineer - Medical devices at Given Imaging (Medtronic)

    Jan 2023 - now

  • Design Quality Engineer - Medical devices at Given Imaging (Medtronic)

    Jan 2020 - Jan 2023