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Design Assurance Engineer | Remote

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 20209

Our client a major multinational here in Galway have an exciting opportunity for a Design Assurance Engineer.

on an initial 12-month contract.


The Role:

In the Coronary/RDN Post Market Design Assurance Department, they focus on partnering with internal and external colleagues to plan and execute Post Market Strategies for continuous improvement of products, methodologies, processes, and departmental interfaces, while working within the organization to build, motivate and lead high-performance teams.


Responsibilities

  • You will be joining a highly motivated team of Post Market Engineers within the Coronary/RDN Design Assurance function. 
  • You will provide Design Assurance support to various OU Sustaining & product Surveillance initiatives. 
  • You will help drive Engagement & mind fullness initiatives ensuring the well-being of yourself and your colleagues. 
  • You will contribute to establishing best practices in accordance with ISO13485/14971, 21 CFR and Corporate Quality standards and Regulatory requirements. 
  • You will contribute to establishing strong working cross-functional relationships across the organization and with partners within a complex technical environment. 
  • You will engage with risk management teams consisting of matrixed resources by providing focused technical guidance. 
  • You will represent the CRDN Post Market department in supporting internal and external audits (MDR/MDSAP/FDA etc…).
  • You will contribute to the continuous improvement strategies. 

Requirements:

  • Minimum of a bachelor’s degree (Level 8 NFQ) in a relevant technical discipline (e.g., Engineering, Mechatronics, Science) and desirably with a minimum 2-year relevant experience.
  • You are a dynamic team player, and can work effectively and proactively on cross-functional teams. 
  • You are a good communicator and fluent in English, both in writing and speaking
  • Experience in some form of technical writing is beneficial. 
  • Working knowledge of Regulatory Standards as applicable.
  • Some formal knowledge of Complaint trending or Post Market Surveillance would be considered beneficial.

For more information or a confidential discussion about this role please contact Michelle Mc Inerney.

michelle.mcinerney@collinsmcnicholas.ie

091 706 717