Extrusion Engineer Pinnacle Partners, Inc. - 4.1 Bloomington, IN Job Details Temp-to-hire $85,000 - $125,000 a year 1 day ago Benefits Profit sharing Disability insurance Relocation assistance Health insurance Dental insurance Tuition reimbursement 401(k) 4% Match Vision insurance 401(k) matching Life insurance Qualifications Statistics Polymers experience in materials engineering Content creation for technical audiences Production data analysis Defect resolution root cause analysis Technical documentation Quality control statistical data analysis Monitoring dimensions Regulatory compliance Dimensional inspection Technical writing experience within manufacturing Equipment troubleshooting Corrective and preventive actions (CAPA) Manufacturing facility experience Dimensional measurements Collaboration with product development teams Extrusion machines Data-driven problem-solving Collaboration with manufacturing teams Biomedical regulatory compliance Technical troubleshooting support

ISO 13485

Cross-functional communication FDA regulations Failure analysis Full Job Description About the Role Pinnacle Partners is recruiting for an Extrusion Engineer in Bloomington, IN. This is a hands-on engineering position supporting plastic extrusion processes for medical device manufacturing. The ideal candidate will have 3+ years of plastics extrusion experience and a strong background in polymer materials, process development, troubleshooting, root cause analysis, and technical documentation. This role will spend approximately 60% of the time on the manufacturing floor and 40% in an engineering/office environment, working closely with Engineering, Operations, Quality, R D, and Regulatory teams to optimize extrusion processes, support new product introductions, and ensure consistent, compliant production.

Key Responsibilities:

Develop, optimize, and document extrusion processes for single-lumen, multi-lumen, and coextruded medical tubing. Work with thermoplastic materials including PEBA, Nylon, Polyurethane, FEP, PTFE, and other engineering polymers. Establish and maintain extrusion process parameter windows, including temperature profiles, screw speed, line speed, draw ratio, vacuum sizing, and other critical process variables. Troubleshoot extrusion processes to ensure products are manufactured accurately, consistently, and efficiently. Analyze process performance and identify opportunities for continuous improvement. Conduct root cause analysis for extrusion-related nonconformances, dimensional deviations, material defects, and other manufacturing issues. Lead or support Corrective and Preventive Actions (CAPA) related to extrusion processes. Apply structured problem-solving methodologies including 8D, 5 Why, Fishbone, and other root cause analysis tools. Collaborate with R D, Quality, Regulatory Affairs, Engineering, and Operations on new product introductions and sustaining engineering activities. Support design transfers and the transition of new products into manufacturing. Support NPI activities and the technical documentation required to bring new products into production. Evaluate, specify, and support commissioning of new extrusion capital equipment, tooling, and automation. Support capital equipment selection and automation improvements. Identify opportunities to improve equipment, processes, productivity, quality, and manufacturing efficiency. Prepare and maintain technical documentation including process specifications, work instructions, validation protocols, and engineering change orders. Support equipment and process validation activities. Contribute to FMEA development, risk assessments, and design controls for extrusion processes. Support investigations into manufacturing nonconformances and develop appropriate corrective actions. Apply statistical analysis and process data to identify trends, variation, and opportunities for improvement. Work with dimensional measurement data and GD&T requirements related to medical tubing. Partner with cross-functional teams to resolve technical and production issues. Provide technical expertise and support to Operations and manufacturing personnel. Support continuous improvement initiatives and help identify ways to improve plastics processing technology. Maintain a strong focus on quality, process consistency, compliance, and customer requirements. Stay current with plastics extrusion technology, materials, processes, and manufacturing best practices. Participate in technical discussions and problem-solving activities with other engineers and subject matter experts. Provide leadership, mentoring, or technical guidance to less experienced engineering or manufacturing personnel as needed. Travel less than 10% as needed to support business and engineering activities. Maintain a strong hands-on presence on the manufacturing floor, with approximately 60% of the role spent supporting production and process activities.

Requirements:

Bachelor's degree in Mechanical Engineering, Materials Engineering, Materials Science, Polymer Engineering, Biomedical Engineering, or a closely related field. 3+ years of experience in plastic/polymer extrusion manufacturing. Experience with plastics extrusion is required; metal extrusion experience alone will not meet the requirements. Medical device or pharmaceutical manufacturing experience preferred. For candidates with an advanced degree, a minimum of 3 years of relevant experience is required. Strong understanding of polymer material properties and their relationship to extrusion processes. Familiarity with Quality Management Systems and regulated manufacturing environments. Familiarity with ISO 13485 and

FDA 21 CFR

Part 820 requirements. Experience with statistical data analysis and process improvement; Minitab or SAS experience preferred. Familiarity with GD&T and dimensional measurement techniques, particularly for tubing or similar precision products. Experience using structured problem-solving and root cause analysis methodologies such as 8D, 5 Why, Fishbone, and CAPA. Strong technical documentation skills. Ability to troubleshoot manufacturing processes and identify root causes of process variation. Ability to work effectively across Engineering, Operations, Quality, R D, and Regulatory functions. Strong analytical and problem-solving skills. Strong communication and collaboration skills. Ability to work approximately 60% of the time on the manufacturing floor and 40% in an office/engineering environment. Ability to work Monday through Friday, approximately 7:30 AM-4:00 PM. Willingness to relocate to the Bloomington, IN area.

Preferred:

Hands-on experience operating, troubleshooting, and optimizing plastic extrusion processes. Medical device or pharmaceutical extrusion experience. Experience with single-lumen, multi-lumen, or coextruded tubing. Experience with PEBA, Nylon, Polyurethane, FEP, PTFE, or similar thermoplastic materials. Experience with New Product Introduction (NPI). Experience with design transfer and product launch activities. Experience with equipment and process validation. Experience developing validation protocols and supporting validation activities. Experience with CAPA and nonconformance investigations. Experience with FMEA and formal risk assessments. Experience working with design controls. Experience leading, mentoring, or training engineering or manufacturing personnel. Experience collaborating across Engineering, Operations, R D, Quality, and Regulatory departments. Master's degree in Engineering, Materials Science, Polymer Engineering, or a related field. Experience with capital equipment selection and commissioning. Experience with automation projects. Experience with statistical process control and advanced data analysis. Experience in a highly regulated manufacturing environment. Experience with continuous improvement and process optimization. Experience working with technical documentation in an ISO 13485/FDA-regulated environment.

Benefits Overview:

$85K-$105K base salary for Engineer II-level candidates. $95K-$125K base salary for Engineer III/Senior Engineer-level candidates. Quarterly bonus opportunity Annual profit-sharing contribution 401(k) with 4% employer match, immediately vested. Medical, dental, and vision insurance. Low employee medical premiums. Company-paid life insurance at 1.5x annual salary. Company-paid long-term disability insurance. Tuition reimbursement. Multiple training and professional development opportunities annually. Monday-Friday, approximately 7:30 AM-4:00 PM schedule. Relocation assistance may be available Explore More Engineering Opportunities This role falls within our Engineering/Manufacturing division , where we specialize in placing professionals in areas such as: Mechanical/Electrical Engineering Manufacturing/Process Engineering Controls Engineering Project Engineering Technical Sales Operations / Plant Engineering Explore additional Engineering roles and learn more about how we support Engineering professionals: Find Jobs or Manufacturing & Engineering Opportunities #ENG123 About Pinnacle Partners For more than two decades, Pinnacle Partners has been connecting top talent with leading employers across Indianapolis, Louisville, Cincinnati, and other cities throughout the Midwest. We specialize in Information Technology, Accounting & Finance, Administrative, Human Resources, and Engineering/Manufacturing, offering contract, contract-to-hire, and direct hire placements. Job Details Bloomington, IN Onsite Up to $125000 per Year Direct Hire