Extrusion Development Engineer: Lead Film Projects & GMP Expert

Polyzen; Apex (NC); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Generous Paid Time Off

401k with excellent company match

Health Insurance with multiple plans

Paid Short Term and Long Term Disabilt

Job summary

Polyzen in Apex, NC seeks an Extrusion Development Engineer to drive extrusion projects from design through commercialization. You will work with Flat Die Extruders, Layflat lines, and laminators, coordinating with Quality, Engineering, and business teams to deliver scalable manufacturing processes.

Candidates should have a BS in engineering and 5–7 years in extrusion or related molding operations, plus GMP/GDP and ISO 13485/9001 knowledge.

Qualifications

• BS in engineering or related field preferred.
• 5–7 years of extrusion or related molding operations.
• Knowledge of GMP, GDP, and ISO 13485/9001 practices.
• Experience with manufacturing process development and capability assessment.
• Ability to translate client requirements into engineering specifications.
• Strong cross-functional collaboration and mentoring skills.

Responsibilities

• Lead multiple extrusion development projects across product lifecycle.
• Design scalable manufacturing processes for production environments.
• Specify tooling, fixtures, and equipment for extrusion at required scale.
• Develop and qualify test and inspection methods for key attributes.
• Troubleshoot and maintain extrusion equipment.
• Follow GMP/GDP and GMP documentation practices.
• Collaborate with Quality and Engineering to drive stage-gate development.
• Ensure adherence to ISO 13485 and 9001, GMP, and GDP standards.
• Assist CAPA activities to improve product quality.
• Train junior extrusion engineers and act as SME.

Skills

Extrusion engineering

Project leadership

Quality systems

GMP/GDP knowledge

Process development

Client liaison

Mentoring

Education

Bachelor’s degree in engineering

Tools

Flat Die Extruders

Layflat extrusion

Laminators

Job description

Polyzen in Apex, NC seeks an Extrusion Development Engineer to drive extrusion projects from design through commercialization. You will work with Flat Die Extruders, Layflat lines, and laminators, coordinating with Quality, Engineering, and business teams to deliver scalable manufacturing processes.

Candidates should have a BS in engineering and 5–7 years in extrusion or related molding operations, plus GMP/GDP and ISO 13485/9001 knowledge.