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Design Assurance Engineer

Job description

Responsibilities

  • This person will use their material knowledge of animal origin (bovine or porcine) and nitinol or any experience with testing of nitinol to help improve design and Quality Assurance in devices.
  • Demonstrating and promoting a commitment to improving patient safety, customer satisfaction and product quality while removing or mitigating against risks associated with the design, use and manufacture of medical devices
  • Ensure NPD and R&D teams are aware of quality standards in place to help with patient safety and compliance to international regulatory requirements
  • Interfaces with R&D, Regulatory Affairs, Clinical Marketing, Process Development and Manufacturing in a project team environment providing technical and Quality systems input to the team
  • Familiarity with requirements and procedures that govern the Product Development Process and Design Control requirements
  • Provides both quality and technical input to the 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
  • Updates Quality policies to ensure compliance with Product Development needs and relay this information to the Product Development Group

 

Requirements

  • Level 8 degree in engineering or science with a minimum of 3 years’ experience in a similar environment
  • Knowledge / understanding of EN ISO 5840-3
  • Basic knowledge of Finite Element Analysis
  • Basic knowledge/understanding of valve testing/kinematics
  • Working knowledge of design assurance and patient safety

 

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