Primary Function of Position: Senior Equipment engineers ensure the efficient and reliable operation of manufacturing equipment used in the production of medical devices. This role involves designing, developing, and maintaining equipment and processes to meet high-quality standards and regulatory requirements. The Senior Equipment Engineer also leads validation activities, troubleshoots technical issues, and collaborates with cross-functional teams to support new product introductions and continuous improvement initiatives. Additionally, they provide technical expertise and mentorship to junior staff, ensuring the overall effectiveness and compliance of the manufacturing operations.
Essential Job Duties:
- Design, develop, and implement equipment and processes for manufacturing medical devices.
- Lead and manage equipment validation activities, including IQ, OQ, and PQ protocols.
- Troubleshoot and resolve equipment-related issues to ensure minimal downtime and optimal performance.
- Collaborate with cross-functional teams to support new product introductions and process improvements.
- Develop and maintain detailed equipment documentation, including specifications, maintenance procedures, and calibration records.
- Ensure compliance with regulatory standards (e.g., FDA, ISO) and company quality policies.
- Provide technical guidance and mentorship to junior engineers and technicians.
- Conduct risk assessments and implement corrective and preventive actions (CAPA) for equipment-related issues.
- Manage equipment procurement, installation, and commissioning projects.
- Monitor and analyze equipment performance data to drive continuous improvement initiatives.