Extrusion Development Engineer

Polyzen, Inc.; Apex (NC); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Generous Paid Time Off

401k with company match

Health Insurance with multiple plans

Short Term & Long Term Disability

Job summary

Polyzen, Inc. is seeking an Extrusion Development Engineer to drive extrusion development projects from concept through commercialization.

You will work with internal stakeholders, vendors, and clients to deliver high-quality extruded films on advanced equipment and maintain GMP/GDP compliance. The role requires 5–7 years of extrusion experience, knowledge of ISO 13485 and quality systems, and the ability to mentor junior engineers while ensuring timely delivery and adherence to safety and

Qualifications

• Bachelor's degree in engineering or related field preferred.
• 5–7 years in extrusion, blow molding, or injection molding operations.
• Knowledge of GMP, GDP, ISO 13485, and 9001 practices.

Responsibilities

• Lead multiple extrusion development projects through the product lifecycle.
• Design scalable manufacturing processes for production environments.
• Specify tooling, fixtures, and equipment for extrusion development at required scale.
• Develop and qualify test methods for key product attributes.
• Troubleshoot and perform maintenance on extrusion equipment.
• Train junior extrusion engineers or operators as SME.

Skills

Extrusion

Process development

Manufacturing process design

GMP/GDP knowledge

ISO 13485 knowledge

Mentoring/leadership

Project management

Communication

Education

Bachelor's degree in engineering or related field

Tools

Extrusion equipment

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