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Manufacturing Engineer (R&D)

Job Title: Manufacturing Engineer (R&D)
Contract Type: Permanent
Location: Galway
REF: 83052
Job Published: over 2 years ago

Job Description

Manufacturing Engineer (R&D)

Our client, a medical device company in Galway are currently looking to recruit a Manufacturing Engineer for their site in Galway.

The purpose of this role is to plan and execute product/process development activities and transfer such processes into the manufacturing environment. The successful candidate will start in R&D and move to production with a new product after 12/18 months.

Main Duties/Responsibilities:
  • Work as part of a team with responsibility for the development of a new product in line with Merit?s
  • Product Development Process with particular focus on the definition, development, testing and
  • validation of device components, assemblies and packaging.
  • Transfer with the product line into production as the technical lead.
  • Can initiate own workload and ensures it is aligned to department and site goals.
  • Leads complex projects with cross functional team.
  • Continually assesses and reviews day to day manufacturing issues/practices.
  • Can identify, gain approval and complete continuous improvement projects.
  • Can prioritise issues as they arise.
  • Completes technically challenging tasks and identifies appropriate resources when applicable.
  • Uses established problem solving techniques to address challenging problems in production.
  • Can compile and report KPI metrics for management review.
  • Can effectively communicate line issues and offer solutions.
  • Generates ECOs, protocols and prototypes under minimum direction.
  • May supervise the work of technicians or others as required.
  • Ensures all products and processes are developed in compliance with regulatory requirements.
  • Performs other related duties and tasks as required.

  • Educational experience of a Bachelor?s Degree in Engineering or technical field related to the department of assignment or industry with five years previous related experience, a Master?s Degree with three years previous related experience, or a Ph.D. A minimum of a Bachelor?s Degree is required for this position.
  • Demonstrated track record in medical device product design & development from concept through commercialisation.
  • Demonstrated experience in Risk Management and executing Failure Mode and Effects Analysis.
  • Demonstrated experience in balloon catheter manufacturing in the areas of balloon forming, catheter assembly and coating are a distinct advantage.
  • Strong analytical, problem solving and project management skills.
  • Willing to take ownership of activities and work under own initiative.
  • Excellent technical report writing skills.
  • Working knowledge of general office computer software and hardware.
  • 2D/3D CAD (preferably Solid works).
  • Knowledge of ISO 13485, MDD and applicable FDA requirements.
For further information on this Manufacturing Engineering role in Galway please contact Tracy Lenihan on 091730022 /
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