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Principal Design Assurance Engineer

Job description

Principal Design Assurance Engineer

Work within one of the world’s largest medical device multinationals focusing on product testing, development and patient safety enhancement. This job is perfect for those with Product Design Quality, Human Factors and Product Risk Management skills. You will be working on NPD projects.

Responsibilities:

  • Lead quality meetings and key core activities for product design assurance.
  • Participate in design reviews and design transfers.
  • Lead failure investigations and root cause analysis of defective products.
  • Represent QA and DA during onsite audits and complete regular internal audits.
  • Implement and develop the Quality Policy and protocols.
  • Design, develop, refine, and validate test methods and inspection procedures. 
  • Guide/author design verification and design validation protocols and reports.
  • Lead NPD design development and quality assurance activities, including:
    • Risk Management and adherence to ISO14971
    • User and Design FMEA
    • Design Verification and Validation
    • Design Change Analysis and Statistical Analysis

 Requirements:

  • 7 years or more experience in Medical Devices or Pharmaceutical Manufacturing with strong knowledge of product design assurance or risk management.
  • Must have a level 8-degree, preferable level 9 Masters.
  • Experience with reliability testing

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

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