Extrusion Engineer/ Manager

Key Responsibilities

1. Process Development & Validation

• Develop, characterize, and document extrusion parameters for medical tubing or molded profiles (e.g., temperature zones, screw speed, die design, vacuum calibration, cooling).
• Lead process validations (IQ/OQ/PQ) and maintain documentation per regulatory standards.
• Support Design Transfer for new medical devices into manufacturing.

2. Equipment & Tooling Engineering

• Oversee setup, calibration, and optimization of single-/multi-lumen, co-extrusion, and/or braided extrusion lines.
• Collaborate with tooling suppliers to design extrusion dies, mandrels, and downstream fixtures.
• Ensure equipment qualification (Installation/Operational Qualification) is completed and maintained.

3. Quality & Compliance

• Ensure all extrusion processes comply with ISO 13485, GMP, FDA QSR, and internal QMS requirements.
• Conduct root cause analysis for nonconformities (e.g., dimensional out-of-spec, gel defects, surface anomalies, lumen collapse).
• Support CAPA investigations and risk assessments (FMEA, pFMEA).

4. Continuous Improvement & Technical Support

• Lead extrusion process improvement initiatives to reduce scrap, improve yields, and enhance product consistency.
• Develop standardized work instructions, SOPs, and training materials for operators.
• Implement SPC, DOE, and data-driven methods to increase process capability (Cpk/Ppk).

5. Cross-Functional Collaboration

• Work closely with R&D, Quality Assurance, Production, and Supply Chain teams on material selection, tooling changes, and manufacturing process optimization.
• Support supplier qualification and material validation for medical-grade polymers (e.g., PTFE, PP, PEBA, PVC, TPE, silicone, PEEK).
• Participate in technical reviews, engineering change orders (ECOs), and documentation updates.

Required Qualifications

• Bachelors degree in Mechanical Engineering, Polymer Engineering, Materials Science, Manufacturing Engineering, Biomedical Engineering, or related field.
• 5+ years of hands-on experience with polymer extrusion processes (ideally in medical device or regulated manufacturing).
• Strong knowledge of medical device regulatory and quality requirements (ISO 13485, FDA GMP, QSR).
• Experience with tubing extrusion (single-/multi-lumen), co-extrusion, or micro-extrusion.

Preferred Skills

• Experience with cleanroom manufacturing (ISO Class 7/8).
• Familiarity with medical-grade polymers and their processing characteristics.
• Knowledge of statistical techniques (DOE, SPC, Minitab).
• Experience with automation, vision inspection systems, or in-line measurement technologies.
• Strong analytical, troubleshooting, and documentation skills.