Manufacturing Engineer with equipment and process validation experience required for permanent role with growing medical devices company in Galway

Responsibilities:

  • Reporting on yield, OEE metrics and product failure investigation
  • Support the introduction of new Products and Process technology through Process development and Validation
  • Use Lean methodologies to drive continuous improvement focused on Quality, Cost, Material flow and layout
  • Lead or actively participate in cross-functional teams to ensure that continuous improvement projects are completed in a timely and efficient manner
  • Preparation and maintenance of manufacturing specifications for specific projects 
  • Ensure effective closure on Quality System documents (Audit Actions, NC’s, CAPA’s, etc)
  • Ensure all production equipment, processes and work areas meet Health & Safety requirements through the completion of the required documentation
  • Support all customer, FDA and NSAI audits when required

Requirements:

  • Minimum of a primary degree in an engineering or technological discipline
  • Minimum of 4 years’ experience
  • Knowledge of equipment and process validation
  • Ability to manage multiple assignments or projects with sound analytical, troubleshooting, and problem solving skills
  • Understanding of ISO 13485 and FDA design and development processes
  • Experience with Lean methodologies ideal
  • Ability to work as part of a multi-disciplinary team with good interpersonal skills
  • Excellent planning and coordination skills and capable of initiating and leading change
  • Ability to present ideas and concepts clearly and effectively to all levels of the company
  • Proficiency in use of desktop software applications such as MS office

Please contact Emer Smith to discuss in confidence

00353578638188

emer@emtechrecruitment.ie 

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