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.
· 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.
· 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]