Design Assurance Engineer – Galway

Interested in working for a leading Medical Device manufacturer? You must have experience implementing standard mechanical techniques throughout your validation activities.

Responsibilities:

  • Plans, conducts and executes design assurance activities.
  • Works closely with teams to establish the system design specifications and product requirements.
  • Performs and documents all engineering studies and reports to satisfy the master verification plan.
  • Participates with the engineering team to establish and review the design FMEA.
  • Routinely provides design assurance guidance and direction to engineers.
  • Support various QA/RA activities.
  • Evaluation of new products, assuring the safety and efficacy of the devices.
  • Design verification and shelf life protocols / reports review.
  • Root cause investigations; drive problem solving efforts for quality issues.

Requirements:

  • BSc. in Engineering, or related discipline.
  • 3-5 years of relevant experience.
  • Experience in design control & risk management.
  • Experience in developing Design Assurance strategies for projects.
  • Audit experience. 
  • Ability to act as a member of a cross-functional team.
  • Ability to work under pressure on highly visible projects.
  • Some travel may be required.
  • Must be authorised to work in Ireland.

Please contact Mary-Ann Keena to learn more

maryann@emtechrecruitment.ie

+353 (0) 83 0220666

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