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Operations
Manufacturing Engineer

Intermediate
Tel Aviv

Responsibilities

  • Create, maintain and improve “low to mid-volume” manufacturing lines, specifying and/or refining BOMs, work-flow processes, manufacturing plans, detailed work instructions, inventory and incoming inspection
  • Provide manufacturing decision-making information by calculating production, labour and material costs; reviewing production schedules; estimating future requirements
  • Analyze manufacturing line risks (PFMEA) to incorporate and validate critical tests during/for manufacturing
  • Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches
  • Identify and implement continuous improvement projects with respect to first-pass yield, cycle time reduction, product reliability, capacity enhancement, cost reduction and engineering change orders that effect manufacturing
  • Take responsibility for maintaining compliance with medical device quality system including CAPA closure, discrepant material dispositions and ECO implementation, under ISO 13485, CE and FDA regulatory guidelines
  •  Maintain all documentation associated with the manufacturing line (DMR and DHR records)
  • Create, improve and maintain work instructions, procedures and processes in relation to manufacturing

Qualifications

  • Degree in Industrial or Mechanical Engineering, or related experience
  • More than 3 years of experience in medical device related manufacturing environment, with significant mechanical/ electromechanical content
  • Previous experience with ERP systems
  • Experience in an ISO 13485, ISO 9001 – advantage
  • Prior experience with complex device manufacturing – advantage
  • Clean room manufacturing experience – advantage
  • IQ/OQ/PQ knowledge – advantage
  • Technical writing capabilities
  • Excellent collaboration and communication skills
  • Multi-Tasking, Organized and Hands On
  • Start Up culture oriented
  • Excellent English language skills (verbal and writing)
  • A technical mindset with great attention to details
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