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 Bachelor’s 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.
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