Process Development Engineer - Technologies The Process Development Engineer is responsible for developing, documenting, validating, and continuously improving processes supporting balloon manufacturing, injection molding, 3D printing, and pad printing technologies. This role serves as the technical owner for assigned manufacturing technologies and partners closely with Operations, Quality, Engineering, and Production to ensure safe, efficient, and repeatable manufacturing processes that meet quality and regulatory requirements. Reporting to the Technologies Manager, this position combines hands-on technical work in the clean room with documentation, process development, tooling design, and operator training. Duties and Responsibilities - Develop, optimize, and sustain manufacturing processes for balloon manufacturing, injection molding, and pad printing.
- Author and maintain SOPs, work instructions, manufacturing specifications, and other controlled documentation.
- Design and build manufacturing tooling and fixtures to improve quality, efficiency, and repeatability.
- Lead process qualification activities, including equipment qualification and IQ/OQ/PQ protocol development and execution.
- Support engineering change activities through DCRs, ECOs, and related documentation.
- Analyze manufacturing data to identify trends, improve yield, reduce scrap, and increase process capability.
- Train production operators and technicians on manufacturing processes, equipment, and best practices.
- Troubleshoot manufacturing equipment and process issues to minimize downtime.
- Collaborate with Quality to investigate nonconformances, implement CAPAs, and support root cause analysis.
- Participate in new product introduction and technology transfer into manufacturing.
- Ensure compliance with ISO 13485, FDA Quality System Regulation, and internal quality procedures.
- Support continuous improvement initiatives across manufacturing technologies.
- Maintain documentation supporting process validation and manufacturing readiness.
- Assist with equipment setup, qualification, and ongoing process monitoring.
- Other duties as assigned.
|