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.
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.
Skills Required
- Bachelor's degree in Plastics Engineering, Polymer Engineering, or Mechanical Engineering
- 15+ years hands-on extrusion process development experience, preferably in medical device manufacturing
- Expertise in micro-extrusion, tight-tolerance tubing, multi-lumen and co-extrusion processes
- Experience processing advanced polymers (e.g., PEEK, TPU, PCU)
- Strong understanding of polymer rheology, material science, tooling/die design, and flow dynamics
- Proven experience developing and implementing process development standards, DOE methodologies, and process characterization
- Experience with process monitoring, automation, and data analytics tools
- Experience ensuring regulatory compliance (FDA), ISO 13485 quality systems, and supporting validation for Class II/III devices
- Mentoring and training experience for engineers and technicians in extrusion process development
- Master's or Ph.D. in relevant field
- Experience with medical-grade thermoplastic materials
- Experience integrating digital manufacturing / IIoT systems into extrusion processes
- Experience with additional polymer processing techniques
Spectrum Plastics Group Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Spectrum Plastics Group and has not been reviewed or approved by Spectrum Plastics Group.
-
Retirement Support — A 401(k) match is included in the core package for full-time employees. This provides employer-backed retirement savings support beyond base pay.
-
Wellbeing & Lifestyle Benefits — Paid Volunteer Time Off, wellness resources, an Employee Assistance Program, and employer‑paid life/short‑term/long‑term disability are part of the offering. These programs extend support for personal wellbeing and community involvement.
-
Healthcare Strength — Health and dental coverage are available, with HSA options noted. The overall package is characterized as solid in multiple descriptions.
Spectrum Plastics Group Insights
What We Do
Spectrum Plastics Group is a global leader in the design, development, and manufacturing of specialty medical components and devices, providing solutions from development through scaled manufacturing for medical and other demanding markets.
