Senior Design Assurance Engineer required by a market leading Medical Device multinational based in Galway to help ensure successful transfer of design to manufacturing.

Key Responsibilities:

  • Plans, conducts and executes design assurance activities.
  • Works closely with product development engineering and the client team to establish the system design specifications and product requirements.
  • Works closely with design, development, quality, regulatory, and the client team to establish and document the master verification plan.
  • Performs and documents all engineering studies and reports to satisfy the master verification plan.
  • Plans, coordinates and executes design verification testing to directly support the master verification plan.
  • Participates with the engineering team to establish and review the design FMEA.
  • Provides design assurance guidance and direction to engineers.
  • Possesses a comprehensive understanding of the application of product-specific standards.
  • Support various QA/RA activities.
  • Leads risk management (ISO 14971) activities for the project.
  • Leads Biocompatibility activities for the project.
  • Evaluation of new products, assuring the safety and efficacy of the devices.
  • Design verification and shelf life protocols/reports review and approval.
  • Lead and own CAPAs as required, drive root cause investigations and problem-solving efforts for quality issues.
  • Clearly present information to Regulatory Affairs to minimize Regulatory Agency questions.
  • Support customer complaint analysis and post market surveillance activities.
  • Generate and approve change requests.

 

Requirements: 

  • BSc. or higher in Engineering, or a related discipline.
  • 5 years relevant experience.
  • Must be able to work independently and as a member of a cross-functional team.
  • Ability to work on highly visible projects in high-pressure situations.
  • Ability to communicate appropriately with different teams.
  • Some travel required.
  • Must be authorised to work in Ireland.

 

Please contact Emer Moore to discuss in confidence
00353578638188       
emoore@emtechrecruitment.ie

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