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Design Assurance Engineer

  • Location:

    Galway

  • Contact email:

    jporter@sigmar.ie

  • Sector:

    Engineering

  • Contact phone:

    091 455305

  • Job type:

    Full Time

  • Job ref:

    JPDESIGNASSUREGALWAYy

  • Salary:

    Negotiable

  • Published:

    10 days ago

  • Contact email:

    jporter@sigmar.ie

  • Consultant:

    James Porter

Job description

Responsibilities

  • Ensure full compliance with global regulations and internal quality assurance procedures during product development and sustaining engineering activities with the aim to improve patient safety, customer satisfaction and product quality
  • Remove any mitigating risks associate with design
  • Ensure the wider teams are aware of their commitment to patient safety and product quality through training and procedure development
  • Work cross functionally with R&D, Regulatory Affairs, Clinical Marketing, Process Development and Manufacturing on wide reaching R&D projects providing support on technical requirements and quality systems
  • Involvement in design reviews, project development/ design change/recertification plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing product lines
  • Work on design quality support projects in the resolution of PIRs, complaints investigation, CAPAs, VIPs, regulatory requirement changes

 

Requirements

  • Level 8 honours degree in Engineering related field with 3 or more years’ experience in a design assurance or similar role in the medical device, pharmaceutical or biotech sectors
  • Knowledge & understanding of EN ISO 5840-3 is essential
  • Material knowledge of nitinol and any experience with testing of nitinol is desirable
  • Material knowledge of animal origin (bovine or porcine) is desirable
  • Basic knowledge of Finite Element Analysis

  

To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E:   jporter@sigmar.ie  

All applications will be treated with the strictest of confidence.  Sigmar will never forward your CV to a third party without prior consent

 

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