Our client a Galway based start up are looking to hire a Design Quality Engineer.
You will work closely with R&D, Clinical, Regulatory and Manufacturing Engineering colleagues you will provide quality expertise. You will contribute to design for manufacturing and design for assembly considerations.
Support Design Verification and Design Validation testing and associated methods.
Lead or support corrective and preventive actions to continuously improve our designs and test methods.
Lead or support Design Controls process and Design Reviews process.
Support compiling technical documentation in relation to regulatory submissions.
Support the development of test methods and associated work instructions as required
Support Human Factors and Usability studies.
Ensure smooth transition of activities from design to manufacturing e.g. transition of dFMEA to pFMEA, transition of Design Specifications to Manufacturing Specifications, transition of Design Test Methods to Process Test Methods, etc.
Work with existing and future external design\manufacturing partners and suppliers.
Have an engineering , scientific or technical degree
Have 3 years+ engineering experience in Design Quality or R&D.
Have worked within an ISO 13485 QMS or equivalent environment
Have strong experience in design controls, design reviews and design change processes
Have experience with electromechanical equipment or components or assemblies
Have strong experience in use FMEA and\or design FMEA
Strong experience in problem-solving & root cause investigations
Advantageous to Have:
Process or test equipment validation experience
Previous experience working in a startup or SME environment
Optimising processes with a view to Design for Manufacturability (DFM)
Validating test methods and test equipment or test software
Strong background in the use of statistical methods
For more information and a confidential discussion on the role please contact Michelle Mc Inerney.
091 706 717