​What you need to know

Our client who are a well tenured medical device manufacturer in the East Galway region are seeking a Design Assurance Engineer to join their team.

In this role the Design Assurance Engineer is accountable for delivering quality engineering assistance throughout every stage of the product development process and facilitating sustaining engineering tasks following the commercialization of the product.

The Design Assurance Engineer will report to the Senior Design Assurance Engineer.

Please note this role is a 1-year fixed term contracted role, going alongside this is an excellent range of benefits and salary.

The hours of work will operate on a 4-day week pattern, Monday to Thursday, daytime hours. Flexibility will be provided in the position.

Your new job

Key duties & responsibilities:

• Participates in the development of new products and technologies and contributes to Design Assurance (DA) activities within a project team.

• Offers guidance in design control and risk management, applying clinical knowledge to shape design inputs and relevant test methodologies.

• Executes test method validations and develops plans, protocols, and reports for design verification, design validation, and usability.

• Takes the lead in managing risk for new product/technology development projects and supports post-market activities, such as generating field assessments and surveillance reports.

• Ensures ongoing compliance with regulatory standards through gap assessments and supports mitigation efforts.

• Assists in design transfer activities, including process validation and material qualifications.

• Manages the audit schedule, both internal and external, and provides representation for Design Assurance in nonconformance reports, complaints, audit findings, and Corrective and Preventive Actions (CAPAs).

Essential Requirements.

• A degree in Engineering or Quality Assurance.

• Previous experience as a Design Assurance Engineer position in the field of Medical Devices.

• Strong technical writer.

• Experience with risk and assessments.

Benefits.

• Pension Contribution.

• Medical Insurance.

• Bonus program.

Apply for this job now by sending in a Word version of your CV or get in touch with Eugene O'Rourke at eugene@matrixrecruitment.ie or alternatively by phone at 087 4075822. 

By applying, you are giving consent for Matrix Recruitment to contact you about this job. We collect your data for recruitment purposes only and will retain it for the duration required as outlined in our privacy policy. All CVs are kept confidential and will not be submitted to any clients without your knowledge and consent. 

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