Design Assurance Manager (15315) Galway, Republic of Ireland

Our Galway based client are now recruiting for a Design Assurance Manager to join their team, for further information please contact Loretta on 086 1838380.

 Key Responsibilities :

  • Driving functional excellence in Design Assurance by providing coaching and mentoring on product design change and material change best practices and ensuring technical excellence.
  • Hiring, guiding, training and developing world-class staff to provide technical leadership for multiple sustaining projects. 
  • Provide leadership to implementation of EUMDR across the Division in partnership with Regulatory and Clinical.
  • Working cross-functionally in identifying and resolving technical issues, takes a pro-active role in building bridges across the organization to mitigate issues.
  • Driving and evaluating project and department progress, technical development plans, and results. 
  • Provide leadership and guidance to support the Quality initiatives including product performance based complaint reduction. 
  • Lead the DA team metrics, CAPA, shelf life, PMS and other initiatives to drive agile and efficient work.
  • Interface with R&D and DA managers to provide prioritization of work for the DA team.

 

Requirements:

 

  • Bachelor's degree  plus 8-10 years of related work experience or an equivalent combination of education and work experience.
  • Proven technical leadership and project management skills in medical device design, development and commercial launch.  
  • Proven key leadership traits of: ability to be independent critical thinker, strong communication skills and ability to build effective cross-functional relationships
  • Ability to interface with customers to gather insight and get organizational buy-in on key design inputs.
  • Understanding of risk management and design controls tools and requirements for medical device product development. 
  • Knowledge/Experience of Design Controls and FDA/ISO Medical Device Regulations. 

 

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