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Process Development Engineer

Job description

Looking for an experienced Process Development Engineer to work for a leading Medical Device company in Galway.  You will be working closely with R&D and Manufacturing to develop new processes and prodcuts.

Key responsibilities:

  • Liase with Equipment Engineering 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.  and summarise, analyse and draw conclusions from test results leading to effective technical resolution.
  • 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 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-ordinate testing of validation units and the compilation, analysis and reporting of the validation results.
  • Supervision of one or more Technicians, managing their technical development and facilitating their daily and project tasks.

Key requirements:

  • Honours Degree - HETAC Level 8 in relevant Technical discipline
  • At least three years experience in a similar role preferably in the Medical Device industry.
  • Demonstrate strong knowledge of DFSS/DMAIC tools
  • Demonstrate strong knowledge and application of Lean methodologies, and process improvement tools in identification and elimination of "waste" process steps  and development of efficient, cost effective equipment and processes.
  • Demonstrate strong knowledge and application of Process and equipment validation techniques, PFMEA’s, and associated regulatory requirements

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

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