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Process Engineer

Job description

Looking for a Process Engineer with Medical Device experience for a new role based in Co. Clare.  The role will be in a new cleanroom with a strong focus on validations and process improvement.

Key responsibilities:

  • Provide strong technical support on process/product technologies to support production.
  • Set up, maintenance of and troubleshooting of production machines.  Root cause and problem solve production issues for Injection Moulding Machines. 
  • Own and complete CAPA’s and NC’s related to production issues. Continuous improvement focus, demonstrating strong knowledge of Six Sigma methodologies
  • Identify and eliminate  "waste" process steps and development of efficient, cost effective equipment and processes. 
  • Liaise with Engineering team or external equipment/tooling or material vendors in the selection, design & development of new (or upgrades to existing) equipment, tooling and materials.
  • Lead the development and execution of experimentation and testing to enable characterisation, optimization and troubleshooting of key processes and equipment. 
  • Co-ordinate the introduction of new processes, equipment and materials including installation, calibration, EHS assessment debug, and all associated process and quality system documentation requirements including technical and process work instructions.
  • Complete or lead the writing and release of process validation documentation including FMEA's, Validation Plans, protocols and reports.
  • Co-ordinate execution and documentation of validation builds, co-ordinates testing of validation units and the compilation, analysis and reporting of the validation results. 

Key requirements:

  • A degree in a relevant engineering subject or diploma with relevant additional medical device experience
  • Minimum of 3 years’ experience in a manufacturing environment Experience and knowledge of injection moulding machines, process set up and optimization.
  • Experience in Blow Moulding would be a distinct advantage.
  • Good understanding of all the regulations governing the quality systems.
  • Technical Writing Experience would be desirable.

If you are interested in this  Process Engineer role, please send your resume to mslevin@sigmar.ie or call me on 091 455 300 for more information.

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