Senior Design Assurance Engineer

1 week ago

Galway, Galway, Ireland Sigmar Recruitment Full time

About your new employer: An innovative and expanding medical device company developing a unique technology in the vascular intervention space. The team is united by a shared dedication to advancing interventional medicine and driving meaningful impact through cutting-edge solutions.

About your new job as a Senior Design Assurance Engineer

  • Provide Design Assurance expertise to R&D teams across assigned projects.
  • Support ongoing product improvements by managing design updates in line with evolving standards and regulatory requirements, ensuring integration into the Quality Management System (QMS).
  • Interpret regulatory requirements for device development and ensure they are effectively addressed in project planning and execution.
  • Take ownership of design input specification development and ensure alignment with project goals.
  • Contribute to the creation and maintenance of Design Input and Output documentation.
  • Lead risk management processes for assigned projects, including design modifications.
  • Drive Human Factors and Usability Engineering activities; maintain the Usability Engineering File for all products.
  • Design, develop, and validate test methods to support R&D efforts and ensure compliance.
  • Prepare and manage design verification and validation (V&V) strategies, including plans, protocols, and reports.
  • Assist R&D with the coordination and execution of Design Reviews and ensure completion of associated documentation.
  • Collaborate with R&D to coordinate non-clinical studies at external facilities.

What skill/experience you need as a Senior Design Assurance Engineer

  • A Bachelor's degree in Engineering, Science, or a related discipline is essential.
  • Minimum of 5 years' relevant experience in the medical device industry, ideally with exposure to stent technologies or Class III devices in a Design Assurance capacity.
  • Strong knowledge of ISO 13485, ISO 14971, and FDA Quality System Regulations (QSRs) is required.
  • Proven experience in risk management, validation, physical testing, and statistical analysis.
  • Excellent communication and organisational skills, with the ability to produce clear, accurate, and well-presented reports.

What's on offer?

  • Full time permanent position
  • Salary: €65,000 - €75,000
  • Competitive Bonus
  • Hybrid working

What's next?

  • Apply now by clicking "Apply Now" or contact me at pkiely@sigmar.ie
  • Or if the job isn't quite right but you are looking for something similar, please get in touch.
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