Principal Process Development Engineer - Extrusion

We are seeking an industry-leading extrusion expert to serve as a Principal Process Development Engineer (PPDE) and Subject Matter Expert (SME) for extrusion technologies across our manufacturing sites. This role will be responsible for establishing and institutionalizing best-in-class process development standards, guidelines, and technical frameworks for a wide range of extrusion processes used in medical device manufacturing.

• Serve as the enterprise-wide technical authority on extrusion processes (e.g., single-lumen, multi-lumen, co-extrusion, and micro-extrusion).
• Provide expert guidance in solving complex process challenges, including material behavior, tooling design, and process optimization.
• Lead root cause investigations and corrective actions for critical extrusion-related issues.

• Develop and deploy standardized process development methodologies aligned with scientific/knowledge-based engineering principles.
• Establish process characterization protocols, DOE, and validation approaches (IQ/OQ/PQ).
• Create design guidelines for tooling, die design, and downstream equipment integration.
• Define critical process parameters (CPPs) and control strategies.

• Identify and drive adoption of advanced extrusion technologies, including micro-extrusion and multi-material extrusion.
• Lead feasibility studies for new materials (e.g., implantable polymers such as PEEK, TPU, PCU).
• Evaluate and recommend new equipment, automation, and digital process monitoring solutions.

• Partner with Product Development, Operations, Quality, and Application Development teams.
• Ensure smooth technology transfer from development to production across sites.
• Standardize best practices across extrusion plants to ensure consistency and scalability.

• Mentor Process Development Engineers and Technicians in extrusion science and engineering.
• Develop and deliver training programs and technical documentation.
• Build organizational competency in extrusion process development and validation.

• Ensure all processes meet regulatory requirements (FDA, ISO 13485) and internal quality standards.
• Support validation strategies for Class II and Class III medical device components.
• Integrate SPC, digital quality systems, and Industry 4.0 tools (IIoT) into extrusion processes.

• Bachelor’s degree in Plastics Engineering or Polymer Engineering or Mechanical Engineering (M.S, Ph.D. preferred)

• 15+ years of hands-on experience in extrusion process development, preferably in medical device manufacturing.
• Demonstrated expertise in:
• Micro-extrusion and tight-tolerance tubing
• Multi-lumen and co-extrusion processes
• Processing of advanced polymers (e.g., PEEK, TPU)
• Proven track record of developing and implementing process standards and scalable solutions across multiple sites.

• Strong understanding of:
• Polymer rheology and material science
• Tooling/die design and flow dynamics
• Scientific extrusion principles and DOE methodologies
• Experience with process monitoring, automation, and data analytics tools.

• Experience in medical-grade thermoplastic materials.
• Experience integrating digital manufacturing / IIoT systems into extrusion processes.
• Experience with additional polymer processing techniques preferred.