Conducts engineering activities and tasks in support of manufacturing requirements. Activities and tasks are conducted on materials, products, processes, and equipment.
This role will support the Balloon Guide Catheter Production Line.
- Leads improvement efforts related to product manufacturing including troubleshooting process problems and implementation of corrective actions.
- Applies creativity, engineering knowledge, practical know-how and project management skills to the design, development and implementation of manufacturing processes and equipment with emphasis on meeting production, quality, and cost objectives.
- Performs engineering work related to procurement, design, fabrication, installation, documentation and implementation of manufacturing equipment, tooling and fixtures.
- Establishes work instructions for manufacturing operations that are easy to understand and follow.
- Supports design and process validation by writing protocols, coordinating validation activities, and writing reports.
- Supervises and coordinates activities of assigned technicians and contractors.
- Provides technical support for equipment calibration and maintenance program.
- Participates in product development team activities including document review, risk analysis, design verification, process validation, design review, and design transfer.
- Maintains records of task/project status.
- Ensures appropriate communication processes are established within and across functional groups. Communicates information related to quality management system effectiveness.
- Works in accordance with quality system procedures.
Bachelor’s degree in Engineering.
Minimum 5 years’ experience in medical device design, manufacturing or quality engineering.