Principal Process Development Engineer - Extrusion

Position SummaryWe 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 ResponsibilitiesTechnical Leadership & SME RoleServe 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 & FrameworksDevelop 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 & InnovationIdentify 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 CollaborationPartner 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 & MentorshipMentor 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 & ComplianceEnsure 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.EducationBachelor’s degree in Plastics Engineering or Polymer Engineering or Mechanical Engineering (M.S, Ph.D. preferred)Experience15+ years of hands-on experience in extrusion process development, preferably in medical device manufacturing.Demonstrated expertise in:Micro-extrusion and tight-tolerance tubingMulti-lumen and co-extrusion processesProcessing of advanced polymers (e.g., PEEK, TPU)Proven track record of developing and implementing process standards and scalable solutions across multiple sites.Technical SkillsStrong understanding of:Polymer rheology and material scienceTooling/die design and flow dynamicsScientific extrusion principles and DOE methodologiesExperience with process monitoring, automation, and data analytics tools.Preferred QualificationsExperience in medical-grade thermoplastic materials.Experience integrating digital manufacturing / IIoT systems into extrusion processes.Experience with additional polymer processing techniques preferred. #J-18808-Ljbffr PPC INDUSTRIES INC