I'm looking for...

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

Google Chrome
Internet Explorer
Mozilla Firefox

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Quality Engineer
Process Engineer
Process Engineer
Dublin North
Validation Lead
QC Scientist
Data Scientist
QC Manager
R&D Manager
Data Scientist
Project Engineer
Head of R&D
Senior R&D Engineer
Limerick City
James Cassidy
Life Science

+353 1 5079250
Connect with me on
Search Results for Design Assurance
Job Title. Location Salary Actions

Senior Design Assurance Engineer

Senior Design Assurance Engineer Our client a Galway based Medical Device company currently seeks a Senior Design Assurance Engineer. Reporting to the Design Assurance Manager the successful candidate will be focused on the development of new technologies Role/Responsibilities Work within the quality system and ensuring that the quality policy and company systems and procedures are complied with in line with the Medical Device Directive 93/42/EEC, Medical Device Directive 2007/47/EC, Medical Device Regulation 2017/745, FDA Quality...

Location: Galway,
Senior Design Assurance Engineer
Galway Not Disclosed

Senior Design Assurance Engineer

Our client a high potential start-up are currently seeking a Senior Design Assurance Engineer to join their team. Reporting to the CTO the Senior Design Assurance will work with the core development team on a second generation delivery system. The Senior Design Assurance will join the team in the advancement of a nitinol implant with first and second generation delivery systems from design, manufacture, verification/validation testing, clinical trial and regulatory approval. Senior Design Assurance will have a hands-on approach to projects with a motivated attitude and strong work e...

Location: Dublin,
Senior Design Assurance Engineer
Dublin Not Disclosed
Other Quality Engineering Jobs
Job Title Location Salary Actions
Senior Quality Engineer Dublin Not Disclosed
Quality Systems Specialist Cork Not Disclosed
Associate Director Quality Systems Limerick Not Disclosed
Supplier Quality - Technical Sourcing Specialist Galway Not Disclosed

Design Assurance Career Profile

Design Assurance

Design Assurance engineers provide quality support to R&D and assist in the scale up and commercialization of product.


  • Support risk management activities
  • Evaluation of new products, assuring the safety and efficacy of the devices
  • Design verification and shelf life protocols / reports
  • Qualification and validation activities
  • Knowledge of regulatory compliance requirements for product design, development, transfer and commercialization activities
  • Adhere to Quality System and Design Control requirements
  • Root cause investigations; drive problem solving efforts for quality issues
  • Manage the compilation of design verification and shelf life data for regulatory submissions to support product approval and release
  • Clearly present information to Regulatory Affairs to minimize Regulatory Agency questions
  • Support customer complaint analysis and post market surveillance activities
  • Generate and approve change requests


  • Bachelor's Degree in Engineering or Science related Discipline (Master's Degree desirable)
  • A minimum of 2 years experience, with at least 1 years experience in the Medical Device industry
  • A minimum of 1 years experience in product & process development