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

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• Operations / Plant Engineering

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