Manufacturing Engineer page is loaded## Manufacturing Engineerlocations: Cork, Irelandtime type: Full timeposted on: Posted Todayjob requisition id: R548723 Work Flexibility: Hybrid Purpose of Role: The Manufacturing Engineer (ME) will provide engineering and process support to ensure successful implementation of 2 D barcoding in line with EU MDR requirements.
This role will focus on supporting technical strategy execution, process validation, and operational readiness across both internal manufacturing and supplier sites.
Key Responsibilities:* Support technical execution of 2 D barcode implementation, including validation activities (VP, IQ, OQ, PQ).* Partner with Quality Engineers (QEs) and Supplier Quality Engineers (SQEs) to assess and confirm laser marking equipment compatibility and process qualification at both supplier and internal sites.* Assist in First Article Inspection (FAI) preparation, reviewing supplier provided verification data and ensuring compliance to marking requirements.* Update and maintain manufacturing documentation (DCP, PFMEA, SOPs) to reflect new barcoding processes.* Collaborate with operations teams to ensure inspection readiness (visual inspection, barcode verifier checks).* Troubleshoot and provide technical support during initial marking trials and confidence runs.* Support scrap management, label obsolescence, and carton switchovers as required for Go-Live phases.* Actively contribute to risk assessments, ensuring process robustness and alignment with MDR and GMP requirements.
Required Skills & Experience:* 2–4 years' experience in a regulated manufacturing environment (medical device preferred).* Exposure to process validation and FAI/PPAP activities in a regulated environment.* Familiarity with laser marking or UDI/2 D barcoding processes desirable.* Strong problem solving and root cause analysis capability (Six Sigma / Lean tools beneficial).* Proven ability to work collaboratively with cross functional teams (QE, SQE, and Operations).
Travel Percentage: 10%
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