Job Description
Extrusion Development Engineer Polyzen - 3.1 Apex, NC Job Details 19 hours ago Qualifications ISO standards Full Job Description
POSITION
Extrusion Development Engineer STATUS:
Exempt REPORTS TO
Engineering Manager REVISED:
23FEB26 DEPARTMENT:
Development Primary Objective 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. Primary Responsibilities 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 setup. 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. Other Duties Adheres to GMP/QSR requirements and follows applicable QMS documentation (e.g., SOP's, Work Instructions) to successfully accomplish job requirements. Follows Personal Protective Equipment (PPE) policies and procedures, including wearing hearing protection, safety shoes, gloves, and eye protection as required. Follows gowning procedures in designated areas. Follows established safety requirements and adheres to the Health, Safety, and Environment Management System. Performs other job-related responsibilities as assigned. Qualifications 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. Competencies Manufacturing or Operations Strategy Deployment:
Support the implementation of a manufacturing or logistics strategy that contributes to organizational success. Personal Accountability:
Holding yourself and others to high standards of accountability, developing the team's autonomy. Product and Technical knowledge:
Understanding the company's core competencies and services provided. Analytical Thinking:
Analyze and synthesize information to understand issues that arise, identify solutions, and support sound decision-making. Communication:
Listen and communicate openly, honestly, and respectfully to drive team culture. Safety:
Understands general hazards and controls in assigned work environment(s). Applies safe work procedures to job tasks. Take responsibility and be accountable for following and observing safety rules. Participates in safety initiatives and guides others Travel Less than 10% between facilities as needed. Equal Employment Opportunity Solesis is committed to Equal Employment Opportunity. It is the policy of the Company to encourage and support equal employment opportunity for all Associates and Applicants without regard to sex, age, race, color, ancestry, religious creed, national origin, pregnancy, physical or mental disability, medical condition, marital status, political affiliation, sexual orientation, disable veteran or Vietnam Era Veteran Status. Americans with Disabilities Act Applicants as well as employees who are or become disabled must be able to perform the essential job functions either unaided or with reasonable accommodation. The organization shall determine reasonable accommodation on a case-by-case basis in accordance with applicable law. Job Responsibilities The statements contained in the job description reflect the general duties and responsibilities considered necessary to perform the essential functions of the job and should not be considered as a detailed description of all the work requirements of the position. Solesis may change the specific job duties with or without prior notice based on the needs of the organization. recblid h0maqtr6owp4lpvxzor0nwlekggqs0
