Are you an experienced Quality or Design Assurance professional looking to take your career to the next level? Are you interested in joining a high growth, well-funded start-up where you will have the opportunity to work on the development of ground-breaking Class II Medical Devices?

I am currently seeking an innovative Senior Design Assurance Engineer to become a key member of the QA/RA team in a fast-paced Galway based start-up company, who are in the pre-clinical stage of development for an innovative device in the vascular space.

You will play a key role in the team, taking a lead on design control and risk management activities, working cross functionally to contribute to Design Verification and Validation strategies, and supporting the development of Test Methods for evaluation, verification and validation of products.

Given the nature of a fast based start-up, the Senior Design Assurance Engineer in this role will also contribute to Quality System and Supplier Quality Management, in addition to other Quality related activities.

They offer a very competitive salary and flexible hybrid working policy.

The Requirements for this role are:

• Bachelor’s degree or higher in Science, Engineering or a related discipline
• 5+ years of experience in a Quality or Design Assurance role in the Medical Device sector
• Previous experience applying Design Control and Risk management requirements as part of the Product Development Process for Class II Medical Devices
• Strong understanding of Quality Systems and Supplier Quality Management
• ISO13485 Lead Auditor training is desirable
  

If this role looks like it might be a good fit for you or you would like some more information, please apply here, or email t.toomey@masonalexander.ie to schedule a confidential conversation.