EU MDR Manufacturing Engineer

Posted 21 September 2022
Job type Contract
DisciplineEngineering Leaders and Specialists
ContactPadraig O Luasa

Job description

A global medical device healthcare solutions company who are committed to improving lives through medical technologies, services, operate across 350 facilities in 150 countries, with an innovative portfolio of over 46,000 patents. They are currently looking for a Manufacturing Engineer for an exciting new project, based in Galway, with flexible hybrid working available.

The Position:

  • Creation of new item/part numbers.
  • Generation of new BOM's/DHR's.
  • Updates to Operating Procedures.
  • Update PFMECA's/MVP's/DMR's to reflect EUMDR related changes.
  • Support Engineering Build Requests (EBR's).
  • Liaise with sustaining manufacturing teams to implement EUMDR.
  • Ensures processes and procedures are in compliance with regulations.
  • Manufacturing Line set-up including IQ's, OQ's and related Validation Documentation.
  • Integration of new production processes with SAP ME.

The Person:

  • Level 8 Degree in Engineering/Science or related discipline with a minimum 2 years relevant direct engineering experience.
  • A dynamic team player who can work effectively and proactively on cross-functional teams, with strong attention to detail.
  • You are experienced with computer literacy and team dynamic skills (accountability, decision-making, feedback).
  • Knowledge of SAP/Agile is an advantage.
  • Strong interpersonal, leadership and team skills.
  • Ability to demonstrate good presentation skills are desirable.
  • A good communicator and fluency in English, both in writing and speaking.
  • Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
  • Develops manufacturing processes that are applicable to statistical process control and may develop those techniques.
  • Develops procedures, PFMEAs, electronic routers and other manufacturing Quality System documentation in accordance with regulatory and internal requirements.
  • Provides guidance to engineering regarding design concepts and specification requirements to best utilize equipment and manufacturing techniques.
  • Ensures processes and procedures are in compliance with regulations.

To learn more, apply online or contact Pádraig on +353 87 428 0873 or please submit an updated CV.