Design Assurance Engineer – Galway

Design Assurance Engineer required by a market leading Medical Device multinational based in Galway.

Key Responsibilities:

  • Performs technical reviews of design documentation and labeling.
  • Coordinates and facilitates completion and update of design risk management documentation.
  • Support new test development and appropriate validation.
  • Quality approver on all relevant records.
  • Plan and conduct software validation on device and supporting software.
  • QA lead for product design transfer/validation strategy development and implementation.
  • Supports external audits including notified body and FDA audits.
  • Promotes the awareness of regulatory and customer requirements.

 

Requirements: 

  • BSc. in Engineering, Technology, or Science. 
  • 2-4 years experience working in a regulated device or pharmaceutical company.
  • Knowledge of mechanical ventilation and accessories advantageous.
  • Excellent data analysis skills.
  • Ability to work within a team environment.
  • Excellent understanding of ISO 13485 and FDA QS regulations.
  • Understanding of R&D stage gate process.
  • Ability to understand and apply relevant medical device standards.
  • Some travel may be required.
  • Must be authorised to work in Ireland.

 

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

Refer a Friend