Job Title: Production Engineering Specialist
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We are seeking a skilled Production Engineering Specialist to join our team. The successful candidate will provide critical support in the implementation of 2D barcoding across both internal manufacturing and supplier sites.
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Key Responsibilities:
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* Support technical execution of 2D barcode implementation, including validation activities (VP, IQ, OQ, PQ).
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* Collaborate 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.
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* Assist in First Article Inspection (FAI) preparation, reviewing supplier provided verification data and ensuring compliance to marking requirements.
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* Update and maintain manufacturing documentation (DCP, PFMEA, SOPs) to reflect new barcoding processes.
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* Troubleshoot and provide technical support during initial marking trials and confidence runs.
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* Support scrap management, label obsolescence, and carton switchovers as required for Go-Live phases.
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* Actively contribute to risk assessments, ensuring process robustness and alignment with MDR and GMP requirements.
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* Provide technical expertise and guidance to cross-functional teams (QE, SQE, Operations) to ensure seamless implementation of 2D barcoding.
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Required Skills & Experience:
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* 2-4 years' experience in a regulated manufacturing environment (medical device preferred).
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* Exposure to process validation and FAI/PPAP activities in a regulated environment.
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* Familiarity with laser marking or UDI/2D barcoding processes desirable.
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* Strong problem-solving and root cause analysis capability (Six Sigma / Lean tools beneficial).
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* Proven ability to work collaboratively with cross-functional teams (QE, SQE, Operations).
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About the Role:
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This is an exciting opportunity for a skilled Production Engineering Specialist to join our team and contribute to the successful implementation of 2D barcoding. If you have a passion for process improvement and a keen eye for detail, we encourage you to apply.
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What We Offer:
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A competitive compensation package, opportunities for professional growth and development, and a collaborative work environment.
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How to Apply:
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To be considered for this role, please submit your application, including your resume and cover letter, through our online portal.
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Contact Information:
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Please note that only applications submitted through our online portal will be considered.
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