Test Method Development & Validation Engineer – REF 227MQ

Headcount Solutions is resourcing a Test Method Validation Engineer for our multinational client in Limerick manufacturing medical devices. There is the option for remote working.

 

Main Responsibilities:

 

·            Development of test methods to support design verification activities in a R&D setting.

·            Design of test fixtures, specifying appropriate test equipment, prototyping, measurement system analysis (Gauge R&R, Attribute Agreement Analysis etc.), Test Method Development, generation of Test Method Validation protocols and reports.

·            Reproduce test rigs from design standards.

·            Product testing and evaluation, completion of test reports.

·            Preparation and presentation of design and project reviews.

·            Source new materials components and equipment.

·            Introduction of new equipment, materials and technologies.

·            Test Method Lead for assigned research & development projects including technical and project management responsibly.

·            Manage and drive project tasks to ensure timely completion of project milestones.

·            Work closely with cross functional groups to achieve project and company goals.

·            Compliance with Quality, Regulatory and company policies and systems.

 

Requirements:

 

·            Degree in Mechanical, Biomedical, Design, Chemical Engineering or similar discipline.

·            3 Years’ post degree experience minimum.

·            Experienced in the use of Minitab software.

·            Experience in executing Gauge R&R studies, Attribute Agreement Analysis and Mintitab comparison tools such as T tests.

·            Advantageous to be familiar with test lab equipment such as Zwick, Instron, Vision systems (Keyence/Nikon/Olympus), Cresent HBLT.

·            Good mechanical design and understanding of engineering fundamentals.

·            Advantageous to possess good working knowledge of Solidworks and/or Pro Engineer CAD.

·            Strong technical writer.

·            Knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820), EU Medical Device Regulation 2017/745 would be an advantage.

 

For further information please contact Mick on 086-0435195 or for details in strict confidence to [email protected]

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