Principal Process Development Engineer - Extrusion

About the Role

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 establish and institutionalize 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.

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.

Requirements

• Education
  • Bachelor’s degree in Plastics Engineering, Polymer Engineering, or Mechanical Engineering (M.S. or 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.