Purpose of Role:
The Manufacturing Engineer (ME) will provide engineering and process support to ensure successful implementation of 2D 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 2D 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/2D 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).
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