Mid-Senior Design Assurance Engineer

Location: Galway, Republic of Ireland
Salary: €45000.00 - €70000.00 per annum + DOE
Posted: over 1 year ago
Role type: Permanent
Industry: Life Sciences & Engineering Practice, Science Leaders & Specialists
Contact name: Aidan Toner
Contact email: aidan.toner@hrmrecruit.com

Job description

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.

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