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Operations
Manufacturing Manager

Intermediate
Tel Aviv

Roles & Responsibilities:

  • Plan, maintain and improve “low to mid-volume” manufacturing lines we accordance to the company’s goals
  • Specifying and refining BOMs, work-flow processes, manufacturing plans, detailed work instructions, inventory and incoming inspection
  • Support manufacturing decision-making information by calculating production, labour and material costs; reviewing production schedules; estimating future requirements
  • Analyse manufacturing line risks (PFMEA) to incorporate and validate critical tests during/for manufacturing
  • Take responsibility for maintaining compliance with medical device quality system including CAPA closure, discrepant material dispositions and ECO implementation, under ISO 13485, CE ad FDA regulatory guidelines
  • Identify and implement continuous improvement projects with respect to first-pass yield, cycle time reduction, product reliability
  • 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 plan determine optimal utilization of manufacturing workers and equipment to meet manufacturing goals.

Requirements:

  • Degree in Mechanical or Industrial Engineering, or related experience – A technical mindset with great attention to details
  • More than 5 years of experience in Medical Device manufacturing environment, with significant mechanical/ electromechanical content
  • Prior experience with complex device manufacturing (an experience with Implantable Devices – an advantage)
  • Previous experience with ERP systems
  • Experience in an ISO 13485, ISO 9001 – advantage
  • Clean room manufacturing experience – advantage
  • IQ/OQ/PQ knowledge – advantage
  • Excellent collaboration and communication skills
  • Multi-Tasking, Organized and Hands On
  • Start Up culture oriented
  • Excellent English language skills (verbal and writing)
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