Design Assurance Test Method Engineer

My Galway based client has a vacancy for a Design Assurance Test Method Engineer:



Function:



It is the responsibility of the Design Assurance Test Method Engineer to develop and validate appropriate test methods to support design related projects and deliverables required by the Product Development Process (PDP). The Design Assurance Test Method Engineer may also provide test method support for manufacturing initiatives. The primary function of this role will be to support the development of Medical Devices.



Duties & Responsibilities:



Drive and/or provide technical support for:

Development of functional test methods

Development of new equipment and fixturing for test methods.

Understanding and integrating clinical relevance

Validation of test methods for Design Verification using appropriate statistical tools

Serve as a Quality extended team member on product development project teams.

Partner with R&D and project Design Assurance engineers to arrive at best technical solutions to support project needs and timelines

Write and execute test protocols to support development, investigation, verification, validation and transfer of functional test methods.

Apply appropriate statistical analysis such as GR&R, and DOE in development, transfer, and validation activities

Integrate lab user needs into TM development (i.e. ergonomics, lab efficiency, etc.)

Coordinate with equipment vendors to identify test equipment that meets test and lab requirements.



Qualifications/Experience:



Bachelor's Degree in Engineering, Science or related discipline

Minimum of 2 years experience, with at least 1 year experience in the Medical Device industry

Minimum of 1 year experience in product / process development

Established experience with product development, equipment & fixturing and solving complex problems that require creativity

Able to deliver on multiple projects simultaneously

Ability for reasoning and logical deduction

Excellent prioritization and communication skills

Excellent technical writing and knowledge of Computer Aided Design programs (e.g. Solidworks)



Salary dependent on experience



To take advantage of this opportunity call Tanya on (090)6493882 or send your cv