Job Detail

Location Galway
Salary Negotiable
Posted
Role Type Permanent
Contact Amanda Reynolds
email technical@hero.ie

Design Assurance Engineer II

Job ID: JOB-11535

Design Assurance Engineer II

My MNC Medical Device client are recruiting a DA Engineer II to join their Structural Heart Design Assurance Group. You will focus on providing Quality support across all aspects of PDP from pre-market product development to post market product surveillance.  You’ll participate in the design process to ensure the performance and safety of the Structural Heart devices is assured and maintained throughout the product lifecycle.

Responsibilities

  • You will serve as extended team member on a PDP Project representing the Design Assurance function and will report dotted line to the quality lead on the project.
  • You will prepare test method validations, design verification and shelf life protocols / reports.
  • You will be responsible for keeping abreast of industry best practice with respect to product design.
  • You will maintain expert, up to date knowledge of developments in regulatory compliance requirements for product design, development, transfer and commercialization activities. 
  • You will be required to liaise with departments, both internally and externally to build strong collaborative partnerships.
  • You will be required to provide Quality input into new product development, process improvements and change control.
  • As required, you will support cross functional teams to design protocols to ensure that new products/ product changes are adequately evaluated/tested with respect to standard requirements.

Experience & Skills

  • We are looking for a qualified person to Minimum of a Bachelors degree (Level 8 NFQ) in a relevant technical discipline (e.g. Engineering, Science) and desirably with a minimum of 2 years relevant experience
  • Initiates and Leads Change, Collaborates and Creates Alignment, Drives Accountability and Thinks Critically and Makes Sound Decisions are a must.
  • Excellent communication and ability to influence is critical to the role.
  • You must be fluent in English, both in writing and speaking. 

For further information on this role in please contact Amanda Reynolds on 0860468858/ technical@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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Amanda Reynolds

JOB-11535

Design Assurance Engineer II

Amanda Reynolds

Role Type Permanent
Contact Amanda Reynolds
email technical@hero.ie
mobile +353 86 046 88 58
linkedIn profile click here

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