Production Engineer (Manufacturing, Onsite)

Job summary

The Production Engineer in Manufacturing Systems is responsible for managing and coordinating manufacturing system activities in a regulated medical device environment. This role emphasizes the implementation of manufacturing changes, production system integration, and administration of Manufacturing Execution Systems (MES). The engineer ensures that manufacturing data, processes, and systems are accurately implemented and maintained before production begins.

Qualifications

• Bachelor’s degree in Engineering, Manufacturing, Industrial Engineering, Information Systems, or a related field.
• Experience in a regulated industry such as medical devices, pharmaceuticals, or aerospace.
• Familiarity with manufacturing systems including ERP, MES, and PLM.
• Ability to adhere to defined procedures and regulated processes.
• Knowledge of labeling control and UDI requirements.

Responsibilities

• Execute and coordinate manufacturing changes across enterprise systems to ensure production readiness.
• Transfer manufacturing data from PLM to ERP, including BOM updates.
• Maintain ERP master data necessary for manufacturing execution with appropriate revision control.
• Administer and configure the MES/eDHR system for manufacturing execution and Device History Record collection.
• Develop and implement changes to materials, work instructions, and manufacturing processes.
• Ensure compliance and accuracy of electronic Device History Records.
• Implement and maintain product labeling within manufacturing systems, including UDI requirements.
• Collaborate with Engineering, Manufacturing, Quality, Supply Chain, and IT to resolve production issues.

Skills

• Strong analytical skills with attention to detail.
• Excellent communication skills, both oral and written.
• Ability to analyze problems and implement solutions effectively.
• Structured working style with strong ownership and accountability.

Education

• Bachelor’s degree in a relevant technical discipline is required.

Tools

• Familiarity with ERP (Oracle), MES, and PLM systems.