The Manufacturing Engineer has a critical role within the Engineering Department, responsible for driving continuous improvement and operational excellence in the production line. This position demands a highly motivated and technically skilled engineer with a deep understanding of the Assembly Process, Integration Process, Calibration Process, Process Validation, Quality Control, and Efficient Production practices.
- Lead and execute process validation (PV) and test method validation (TMV) activities for the production line.
- Develop and implement robust validation protocols and plans ensuring compliance with regulatory requirements and internal quality standards.
- Analyse and interpret validation data, identify potential risks and improvement opportunities.
- Prepare and submit validation reports for internal approvals.
- Partner with the Production Managers to optimize production processes for efficiency and cost-effectiveness.
- Oversee the calibration and maintenance of production equipment to ensure consistent output and product quality.
- Partner with raw material and component suppliers, ensuring on-time delivery and consistent quality.
- Provide technical support to the entire production team, including training, troubleshooting, and problem-solving.
- Lead implementation of engineering change orders (ECOs) impacting the product, production line and supplier processes.
- Act as Change/Solution Owner as it is described separately in Operation Org.
- Manage and lead production technical issues and problem solving
- Maintain and update Work Instructions, Forms and other supportive documentation
- Write and implement Test Reports related to Manufacturing Engineering
- Participate in GAMBA meetings