Principal Process Development Engineer - Extrusion

DuPont™ Spectrum™; Sandy (UT); On-site; USD 180,000 - 240,000; Full time

Job summary

DuPont Spectrum seeks an industry-leading Principal Process Development Engineer (SME) for extrusion technologies in medical device manufacturing. You will establish best-in-class process development standards, guidelines, and technical frameworks across sites, driving innovation and quality.

You will mentor engineers, lead cross-functional collaborations, and ensure regulatory compliance (FDA, ISO 13485) while advancing digital monitoring and IIoT integration in extrusion processes.

Qualifications

• 15+ years of hands-on extrusion process development experience.
• Experience in medical device manufacturing is preferred.
• Proven track record developing standards and scalable solutions across sites.
• Expertise in polymer materials used in implantable applications.

Responsibilities

• Serve as enterprise-wide technical authority on extrusion processes (single/multi-lumen, co-extrusion, micro-extrusion).
• Provide guidance solving complex process challenges including material behavior, tooling design, and optimization.
• Lead root cause investigations and corrective actions for extrusion issues.
• Develop and deploy standardized process development methodologies and DOE/validation approaches.
• Create design guidelines for tooling, die design, and downstream equipment integration.
• Define CPPs and control strategies to ensure robust manufacturing.
• Identify and drive adoption of advanced extrusion technologies; assess new materials.
• Lead feasibility studies for new materials and equipment; consider IIoT/automation.
• Collaborate with Product Development, Operations, Quality, and Applications teams.
• Mentor engineers and technicians; deliver training and documentation.
• Ensure regulatory compliance with FDA and ISO 13485; support validation strategies.

Skills

Extrusion expertise

Single-lumen extrusion

Multi-lumen extrusion

Co-extrusion

Micro-extrusion

Polymer science

DOE

Tooling design

Data analytics

Process characterization

Education

Bachelor’s degree in Plastics/Polymer/Mechanical Engineering

Job description

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.

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.

Qualifications

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.