Senior Process Development Engineer

Process Development Engineer

Job Responsibilities

• Develop and implement new manufacturing processes for new disposable medical devices.
• Perform Design of Experiments for process definition and to optimize equipment parameters for new and/or existing processes.
• Create documentation to support new and improved manufacturing processes.
• Use Six Sigma, Lean, and Mistake proof methodologies in the development of manufacturing processes to implement processes that are ‘born lean and capable’.
• Write and perform process validations (IQ, OQ, PQ/PPQ) and validate methods for inspection for verification and process controls.
• Interface directly with assemblers, production supervisors, leads, engineers and management daily.
• Coordinate with the suppliers and external resources needed in developing and implementing new process/product plans.
• Work as part of a development team in developing and implementing new ...