Job Title:
Manufacturing Engineer
About the Role:
The Manufacturing Engineer will provide engineering and process support to ensure successful implementation of 2D barcoding in line with EU MDR requirements.
* 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.
This role will focus on supporting technical strategy execution, process validation, and operational readiness across both internal manufacturing and supplier sites.
Key Responsibilities:
The Manufacturing Engineer will be responsible for:
1. Supporting technical execution of 2D barcode implementation, including validation activities (VP, IQ, OQ, PQ).
2. Partnering 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.
3. Assisting in First Article Inspection (FAI) preparation, reviewing supplier provided verification data and ensuring compliance to marking requirements.
Required Skills & Experience:
To be successful in this role, you will need:
* 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.
Benefits:
This role offers the opportunity to work collaboratively with cross-functional teams and contribute to the success of our organization.
Contact Information:
Please visit our website for more information about this role.