Extrusion Development Engineer

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 is a leading developer and manufacturer of customized polymer-based materials, films, components, and assemblies for the medical device industry. Our range of materials and processing technologies allow us to provide optimum solutions for innovation-driven companies, ranging from entrepreneurial start-ups to major medical device manufacturers. From prototype development through full-scale production, we take pride in our quality, technical expertise, and customer service, and we strive to provide the best value throughout the product life cycle.

1st shift Monday-Friday 8:00 am-5:00 pm

About the role:

The Extrusion Development Engineer is responsible for driving extrusion development projects through the product life cycle by aiding in the development, validation, and commercialization of extruded films on machines such as Flat Die Extruders, Layflat Extrusion, and Laminators. This role will engage with key internal operational stakeholders and grow their business acumen by working with our business development teams, vendors, and clients. This role is a key contributor to the Solesis organization in achieving company metrics: on-time delivery, revenue, quality, and safety.

What you will do:

• Leads multiple projects for extrusion development in various stages of the product lifecycle in line with agreed commitments to respective clients.
• Designs manufacturing processes that are scalable to a production environment based on customer design and volume requirements.
• Specifies tooling, fixtures, and equipment for the extrusion development process at the required scale and manufacturing throughput.
• Develops and qualifies appropriate test and inspection methods for key product attributes.
• Troubleshoot and complete general maintenance of extrusion equipment.
• Ability to assemble and disassemble extruders for cleaning and/or job changes that require different tooling with a new set up.
• Follow all Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) when completing daily tasks.
• Partner cross-functionally with Quality and Engineering Leadership to drive development through the stage gate process.
• Partner with Quality to ensure manufacturing teams are maintaining product adherence that complies with ISO 13485 and 9001 regulations, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and all safety requirements.
• Support the Quality team with any CAPA-related activity to complete root cause analysis and improve overall quality and performance of the products being manufactured for customers.
• Comply with and follow all Standard Operating Procedures (SOPs) and ensure all quality documentation is completed correctly.
• Train junior-level extrusion engineers or operators and act as the subject matter expert (SME) for all things extrusion engineering.

Who you are:

• Bachelor’s degree in business, operations management, engineering, or a similar related field preferred.
• Minimum of five (5) to seven (7) years of experience in extrusion, blow molding, or injection molding operations.
• Knowledge of machine operations that pertain to various polymers and extrusion.
• Possess knowledge of ISO 13485, 9001, and GMP practices or possess the ability to understand and enforce the practices.
• Ability to follow and make recommendations and changes to Work Instructions (WIs) and Standard Operating Procedures (SOPs).
• Experience with manufacturing process development, qualifications, and capability assessment.
• Ability to understand the client’s needs, how the needs relate to the scope of the project, and how changes will affect other systems.
• Ability to translate client inputs into engineering requirements based on technical skill set.
• Ability to explain technical concepts to internal and external project stakeholders, including process capabilities, limitations, and areas for improvement.
• Ability to prioritize and delegate tasks as appropriate to meet project objectives.
• Ability to mentor junior-level engineers.
• Excellent interpersonal skills with proven ability to get along well with others and work in a team environment.
• Good presentation skills and the ability to present on a one-to-one basis and to small groups.
• Generous Paid Time Off
• 401k with excellent company match
• Health Insurance with multiple plans to choose from
• Paid Short Term and Long Term Disability