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Senior Design Assurance Engineer

  • Sector: Engineering
  • Contact Email: michelle.mcinerney@collinsmcnicholas.ie
  • Job Ref: 22041

Our client a Galway based start up are looking to hire a Senior Design Assurance Engineer.

The Role:

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.

Responsibilities:

  • 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.

Requirements:

  • 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.

michelle.mcinerney@collinsmcnicholas.ie

091 706 717