Principal Extrusion Process Architect – Medical Devices

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

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.