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Manufacturing Engineer

Job description

Looking for a Manufacturing Engineer with at least three years experience in the Medical Device industry for a new role based in Galway.

Key responsibilities:

  • Support the finished device manufacturing subcontractors and suppliers to ensure that the  product quality, regulatory & business requirements are met.
  • Track and report progress across projects by reviewing schedules and due dates, identifying risks and assisting teams with contingency plans.
  • Provide manufacturing engineering support to process and product development projects including responsibility for reporting on project activities.
  • Review and contribute to supplier process validation and risk management activities.
  • Support resolution of SCARs, CAPAs & NCs ensuring effective solutions are identified, challenged and implemented.
  • Assess and approve process changes ensuring product impact is appropriately considered.
  • Compile any necessary equipment/capital authorisation requests supported with appropriate justifications and alternative options.
  • Communicate effectively with all Internal & External Stakeholders.
  • Collaborate with key suppliers and their production/manufacturing teams to drive and support process/product improvements/developments and lean initiatives.
  • Ensure all health, safety and environmental requirements are met.
  • The role will involve some European travel to suppliers (up to 20%).

 

Key requirements

  •  Degree Level (Level 7 or Level 8 FETAC) in a relevant engineering or science discipline.
  • A minimum of 3 years’ relevant experience in the medical device industry in a team-based manufacturing or engineering role.
  • Demonstrated ability to plan and complete tasks to defined timelines.
  • Experience in performing process validation and risk management activities is required.
  • Experience of managing internal/external relationships is required.
  • Strong decision making and problem-solving skills. Excellent verbal and written communication skills.
  • Self-motivated, with focus on Quality, Delivery and Cost.
  •  Experience with lean/six sigma and value improvement project experience is preferred.
  • Nitinol stent and catheter delivery system manufacturing experience is an advantage.

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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