Roman Zakharov

New Product Introduction Engineer at Radiaction Ltd.
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Contact Information
us****@****om
(386) 825-5501
Location
Israel, IL
Languages
  • English Full professional proficiency
  • Hebrew Native or bilingual proficiency
  • Russian Native or bilingual proficiency

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Experience

    • Israel
    • Medical Equipment Manufacturing
    • 1 - 100 Employee
    • New Product Introduction Engineer
      • Apr 2022 - Present

    • Israel
    • Medical Device
    • 1 - 100 Employee
    • Engineering Process Engineer
      • Nov 2014 - Apr 2022

      • Lead and responsible for the segment of dry production processes in stents’ manufacturing – such as laser cutting, laser welding and mechanical processes. Sustaining of processes (production) and new processes (coming from R&D). • Processes development of laser cutting and laser welding technologies using of different laser types such as Fiber, ND-YAG and Femto lasers. From the initial requirements stage, through picking the proper machine/process, performing tests and eventually approving the process for commercial production. • Planning, writing and executing validation of processes and equipment (Process Validation) - according to IQ/OQ/PQ methodology and quality requirements. • Leading and writing of Engineering changes (ECRs) - definition of change, risk analysis, tasks planning and managing. • Leading of yields improvement in production – from the data collecting and data analysis stage, through finding the right solution and to full implementation and tracking of the improvement. • Participating in regulatory audits performed by regulatory bodies such as FDA, TUV-SUD. • Re-location and re-validation of production lines. • Supporting and guiding R&D teams while working on new product to achieve stable product and according to good-manufacturing practices. Suggesting potential improvements in early stage of development. Show less

    • United States
    • Hospitals and Health Care
    • 700 & Above Employee
    • NPI Manufacturing Product Leader
      • 2008 - Mar 2014

      * Design Transfer Leader of NPI products from development to production * Manufacturing Process Validation for NPI products and lines* Jigs and equipment qualification using IQ/OQ/PQ methodology* Maintenance and improvements (ECR/ECO) of existing product Installed Base * Creation of production processes and assembly/test procedures* DFM/DFT improvements for new design* Agile PLM configuration control

    • Mfg. Engineering & Intergation Engineer
      • Jul 2005 - 2008

      * Integration team technical leader providing support to production line and R&D teams* Jigs definition and build * Finished product testing and configuration* Service repairs for local and abroad customers

Education

  • Netanya Academic College
    Bachelor's degree, Business Administration and Management, General
    2011 - 2014
  • Ort Hermlin College Netanya
    Practical Engineer, Electrical and Electronics Engineering
    2000 - 2002

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