Our client a Galway based start up are looking to hire a Senior Design Assurance 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.
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.
Support Design Verification and Design Validation testing and associated methods.
Together with the R&D team, plan & support builds for R&D testing, product verification, clinical trials and commercial use of patient-facing medical devices.
Lead the transfer of an assembly line for electromechanical medical device(s), with guidance from the Project Manager and Quality Director.
Validate equipment and processes as required.
Work with existing and future external manufacturing partners and suppliers.
Continually look for opportunities to optimise processes.
Have an engineering , scientific or technical degree
Have 6 years+ engineering experience working within a manufacturing environment.
Have worked within an ISO 13485 QMS or equivalent environment
Experience optimising processes with a view to Design for Manufacturability (DFM)
Experience with Electromechanical components or assemblies
Installing and validating new equipment & processes & test methods
Problem solving skills & root cause investigations
Advantageous to Have:
Qualification: Lead Auditor Certification
Experience: Experience working within a manufacturing environment
Working with PCB & electrical components
Process validation experience
Processing polymeric/electromechanical components
Previous experience working in a startup or SME environment.
For more information and a confidential discussion on the role please contact Michelle Mc Inerney.
091 706 717