Roman Zakharov
New Product Introduction Engineer at Radiaction Ltd.- Claim this Profile
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English Full professional proficiency
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Hebrew Native or bilingual proficiency
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Russian Native or bilingual proficiency
Topline Score
Bio
Experience
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Radiaction Ltd.
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Israel
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Medical Equipment Manufacturing
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1 - 100 Employee
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New Product Introduction Engineer
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Apr 2022 - Present
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Medinol
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Israel
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Medical Device
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1 - 100 Employee
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Engineering Process Engineer
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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
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GE HealthCare
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United States
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Hospitals and Health Care
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700 & Above Employee
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NPI Manufacturing Product Leader
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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
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Mfg. Engineering & Intergation Engineer
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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
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Education
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Netanya Academic College
Bachelor's degree, Business Administration and Management, General -
Ort Hermlin College Netanya
Practical Engineer, Electrical and Electronics Engineering