We are seeking a Process Engineer to join our growing Engineering team. This is an exciting opportunity to play a pivotal role in scaling the manufacturing of an innovative Class III medical device, driving process validation, continuous improvement, and the implementation of new processes from development through production.
Responsibilities
- Lead process improvement initiatives for the company's flagship product.
- Plan, execute, and document manufacturing process validation activities.
- Validate existing production processes to ensure compliance, consistency, and efficiency.
- Support the development, implementation, and transfer of new manufacturing processes into production.
- Collaborate closely with cross-functional teams, including R&D, Engineering, Quality, Production, and Operations.
- Identify opportunities to optimize processes to improve product quality, manufacturability, and operational efficiency.
- Ensure all process validation activities are performed in accordance with applicable quality and regulatory requirements.