Dor Rosenfeld

Experience

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  Comply Ltd

  Jan 2017 - Jan 2019

  Software V&V Engineer

  *Create and execute software verification and validation (V&V) plans and protocols.* Write software test reports (STRs) and log evidence of testing activities.* Identify software problems, evaluate the risk associated with software problems, and work with the engineering team to handle software defects identified during software testing.* Summarize and document the results of V&V testing with respect to the defined User requirements specifications/ Functionality specifications (URS/ FS) and risk.*Review and contribute to risks evaluations, establishing software requirements, and technical documentation developed during the Software Development Lifecycle and in servicing activities* Experience with software as a medical device (SaMD)-The ProAir® Digihaler app (A product of Teva Pharmaceutical Industries Ltd.). * Experience with mobile testing (Android and iOS).* knowledge of the Design Control Regulations in 21 C.F.R. 820.30 and Quality System Regulation (21 C.F.R. 820).* Experience using an eQMS for document control and management such as MasterControl, Jira, TestRail, KMM and HPQC. רוצה לראות פחות

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  West Pharmaceutical Services

  Jan 2019 - Jan 2021

  *Understanding the user needs, product, business and marketing requirements, and converting them to product specifications requirements*Support and participate in applicable design control activities *Provide technical knowledge of system engineering and its application to developing cost effective, reliable and high-quality solutions that address customer and business needs *Participate in risk management activities; identify potential risks and find solutions to prevent/mitigate these risks - Responsible for the risk management documents such as RMP, Risk analysis (dFMEA), hazard analysis and RMR in accordance with the ISO 14971 standard.*Create, maintain and update Design History File content. *Author, review and approve product development / Verification / R&D related documentation Initiate, perform and approve R&D technical design reviews. *Overall responsibility of device/system performance, quality and technical implementation. רוצה לראות פחות *Performs data analysis and write technical documents such as verification and validation (HW and design) plans, protocols, and reports.* Execution of test plans and protocols; and resolving deviations.* Verifying product designs according to internal quality standards and regulatory requirements; EMC, Safety, Environmental and IP code testing according to the standards. *Familiar with ISO 11608 series: Needle-based injection systems for medical use (11608-1 and 11608-4)*Familiar with IEC 60601-1 series: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance ( IEC 60601-1, 60601-1-2 and 60601-1-6) רוצה לראות פחות

  • R&D Engineer

    Jan 2020 - Jan 2021

  • Design Verification Engineer

    Jan 2019 - Jan 2020
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  LTS Lohmann Therapie-Systeme AG

  Jan 2021 - now

  Sr. R&D System and Risk Engineer - Risk Lead

  *Responsible of the risk management activities of the medical device through its life cycle*Create/update risk analysis for new and existing products, including mechanical, hardware and software aspects *Focus on Risk Management activities related to the review of Non-conformances, Complaints and CAPA*Support Lifecycle Risk Management activities and manage Process/Design FMEAs across multiple product lines*Perform risk assessments for change control activities related to design change (ECR/ECO)*Identify Cyber Security potential risks and responsible and suggest applicable mitigations to reduce risk to acceptable level *Identify potential risks in the end to end development- Processes including material handling, transportation, sterilization and packaging.*Attend Nonconforming Material Report (NCMR) and Complaint meetings relevant to one’s scope and update FMEA report when judged necessary.*Subject Matter Expert on design control and risk management processes, e.g., FDA 21 CFR 820.30 and FDA guidance; European MDD and MDR; ISO 13485 and ISO 14971.*Understanding the user needs, product, business and marketing requirements, and converting them to product specifications requirements*Working in collaboration with the different technical disciplines (Electrical, Mechanical, Software), as well as the other groups (Regulatory, Quality, Manufacturing) to support and perform ongoing R&D activities as part of Product Life Cycle. רוצה לראות פחות