Principal Process Development Engineer - Extrusion

Job Details

Job Location: Apollo Sandy - Sandy, UT 84070

Position Type: Full Time

Job Shift: Day

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.

QualificationsEducation

• 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)

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.