Manufacturing Engineer – Galway

If you have experience working in a regulated medical device environment with a focus on meeting quality service and cost objectives then this is the job for you!

Responsibilities:

  • Work as part of the NPI team to drive product and process improvements.
  • Manage new designs through product lifecycle into manufacturing.
  • Work closely with experts to ensure all new product fit within existing manufacturing capability.
  • Work closely with Lean and operations teams to ensure that any new processes developed meet manufacturing standards.
  • Manage a variable workload across different projects to meet NPI requirements.
  • Design and introduce manufacturing processes for new products.
  • Ensure that complete and effective validations are carried out on all processes before transferring to manufacture including IQ, OQ, PQ & PPQ.
  • Implement permanent and effective technical / system solutions to problems.
  • Maintain high compliance standards in line with Medical Devices manufacturing requirements.
  • Applying Lean principles to identify and develop improvements.
  • Investigate new process technologies and evaluate potential competitive advantage.
  • Manage external relationships with Technology providers / Suppliers.
  • Ensure that all Health, Safety and Environmental requirements are fulfilled.

Requirements:

  • BSc. Engineering degree, or equivalent qualification.
  • 2+ years’ experience in a similar role.
  • Strong technical background and capabilities.
  • Knowledge of ISO and FDA compliance with an emphasis on validation.
  • Knowledge of six sigma methodology and lean manufacturing principles.
  • Ability to solve problems with innovative and cost-effective solutions.
  • AutoCAD, Solid works and Minitab experience preferable.
  • Knowledge of equipment, process and product validation processes.
  • Previous experience of working within a medical device environment.
  • Strong mechanical background with a good working knowledge of metals & plastics processing a distinct advantage.
  • Experience in the development of test methods and associated product testing.
  • Knowledge of change management in medical device environment advantageous
  • Must be authorised to work in Ireland.

Please contact Emer Moore to discuss in confidence

00353578638188

emoore@emtechrecruitment.ie 

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