Process Development Engineer II
Core
Develop robust, capable, cost-effective, and safe manufacturing processes and support the transfer of new products and processes into commercial production.
Role type
Process Development Engineer II
Builds
Manufacturing processes, equipment, and materials for commercial production
Domain
Medical device manufacturing
Required skills
Process design, optimization, and validation; DFSS/DMAIC tools; Lean methodologies; PFMEA; Equipment selection and development; Test execution and analysis; Regulatory compliance documentation
Preferred skills
Lean Six Sigma certification; New Product Introduction (NPI) experience; Process validation experience; Machine vision technology experience; Medical device industry experience
Technologies
DFSS, DMAIC, PFMEA, Lean methodologies, vision inspection systems, automated inspection equipment, machine vision technologies
Responsibilities
Support design, optimization, and troubleshooting of process technologies; Provide input on equipment and tooling selection and development; Execute experimentation and testing to characterize and optimize processes; Support introduction of new processes, equipment, and materials including installation and calibration; Apply Lean methodologies to eliminate process waste; Support equipment and process validation including writing validation documentation
Seniority
Mid-level, hands-on IC with mentor assistance