Principal Process Development Engineer - Extrusion

Establish and institutionalize best-in-class process development standards, guidelines, and technical frameworks for single-lumen, multi-lumen, co-extrusion, and micro-extrusion processes across manufacturing sites. Serve as the enterprise-wide technical authority on extrusion technologies, providing expert guidance on material behavior, tooling design, and process optimization while leading root cause investigations for critical issues. Develop standardized methodologies, process characterization protocols, and design guidelines for die and downstream equipment integration, defining critical process parameters and control strategies aligned with scientific engineering principles. Partner with Product Development, Operations, Quality, and Application Development teams to ensure seamless technology transfer and standardize best practices across extrusion plants. Mentor engineers and technicians in extrusion science, deliver training programs, and drive the adoption of advanced technologies and digital monitoring solutions. Ensure all processes meet FDA and ISO 13485 regulatory requirements while supporting validation strategies for Class II and Class III medical device components.