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Design Assurance Engineer

Reference:JOM/AUGC-571333
Location: Galway
Qualification:Degree
Experience:2-3 Years
Job Type:Permanent
Salary:Not Disclosed
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May be suitable for: Design Assurance

JOM/AUGC-571333

Design Assurance (DA) Engineer


Location Galway

Area Medical Devices

An exciting Design Assurance Engineer role is now available in a progressive Medical Device company in Galway, excellent package and benefits including 4 day working week with some opportunity to work from home.

Responsibilities

  • Understand clinical application of the product, utilizes clinical knowledge while supporting development of design inputs and clinically relevant test methodologies.
  • Develop and execute test method validations.
  • Develop design verification, design validation, and usability plans, protocols, and reports.
  • Leads execution of risk management activities for new product/technology development projects.
  • Supports post market activities including but not limited to- generating field assessment and post market surveillance reports.
  • Promotes ongoing compliance to the applicable regulatory standards by performing standards gap assessments and supports mitigation activities.
  • Support design transfer activities including process validation and material qualifications.
  • Support external and internal audits and provide Design Assurance representation for nonconformance reports, complaints, internal and external audit findings and CAPAs
Qualifications
  • An Engineering or Quality Assurance Degree or equivalent experience.
  • A minimum of 3 years post qualification experience as a Design Assurance Engineer within a Medical Device or regulated environment.

Competencies and Attributes
  • Understand regulatory requirements for the product, supports pre-submissions, submissions, and questions from the regulatory agencies.
  • Strong technical writing and verbal communication skills.
  • A good team player who works effectively on their own and with peers from cross functional areas.
  • Takes an analytical approach to problem solving with capacity to make sound judgements

Any applicant must be eligible to work in Ireland. Existing work permit or EU passport required. No visa sponsorship will be offered with this role.

Contact Joan O’Malley at 087-1897333 for more details.



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