Principal Process Development Engineer - Extrusion
About The Position
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.
Requirements
- Bachelor’s degree in Plastics Engineering or Polymer Engineering or Mechanical Engineering (M.S, Ph.D. preferred)
- 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.
- 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.
Nice To Haves
- Experience in medical-grade thermoplastic materials.
- Experience integrating digital manufacturing / IIoT systems into extrusion processes.
- Experience with additional polymer processing techniques preferred.
Responsibilities
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
