Our client is a world leading medical device company based in Galway City. With a market presence in over 90 countries, across 3 continents, this expanding company are seeking a skilled Design Assurance Engineer to join their team.

The Role:

Reporting to the Design Assurance Manager, you as Design Assurance Engineer, supported by your team, will be working with Quality and R&D teams carrying out the following:

• Support research pipeline projects as needed
• Facilitate Design Controls, Risk Assessments and FMECA drafts
• Support specification and drawing development with Regulatory and Quality requirements in mind
• Design and develop test method validation and equipment management
• Coordinate with Third Party Manufacturers and R&D to support investigational studies

The Person:

In order to undertake their duties effectively, the DA Engineer must have:

• A degree in Science or Engineering and have a Quality Engineering qualification (ASQ CQE)
• 3+ years' experience in Medical Device Industry
• Experience of Design input/output review and management of a Design History File
• Experience in statistical analysis and validation advantageous
• Firm grasp of ISO 13485, ISO 14971 and FDA QSRs
• Technical knowledge of Drug elution stents/balloons and/or labelling desirable
• Strong communication skills

The Benefits

This permanent Mid - Senior Design Assurance Engineer position offers the following benefits:

• Competitive salary (Dependant on Experience)
• Basic holiday entitlement of 23 days, with an increase of one day after each of 2 and 5 years' service (ie a maximum of 25 days after 5 years)
• Personal employee and dependents healthcare cover
• Life assurance of 4 x salary
• Annual bonus scheme based on the achievement of corporate and personal objectives

To discover more about this opportunity, apply now or contact Aidan Toner at HRM on +35391 782110 for a confidential discussion.