Principal Process Development Engineer Extrusion

Position Summary

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.

The ideal candidate will bring deep technical expertise a track record of innovation and the ability to elevate organizational capability through knowledge-based process development standardization and cross-site collaboration.

Key Responsibilities

Technical Leadership & SME Role

• 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.

Process Development Standards & Frameworks

• 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.

Technology Development & Innovation

• 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.

Cross-Functional & Cross-Site Collaboration

• 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.

Capability Building & Mentorship

• 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.

Quality & Compliance

• 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.

Education

• Bachelors degree in Plastics Engineering or Polymer Engineering or Mechanical Engineering (M.S Ph.D. preferred)

Experience

• 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.

Technical Skills

• 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.

Preferred Qualifications

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