Senior Engineer, Extrusion

Position Summary 

The Extrusion Engineer is responsible for optimizing and sustaining extrusion manufacturing processes to improve product quality, productivity, and operational efficiency. This role leads continuous improvement and cost-reduction initiatives, provides technical support for complex process issues, develops process standards, and collaborates cross-functionally to ensure reliable and compliant manufacturing operations. The Extrusion Engineer drives process stability through data analysis, problem-solving, equipment validation, and implementation of best practices.

Essential Duties & Responsibilities

• Assign and supervise personnel in your area and plan workflow to facilitate continuous flow as well as Project Completion. conducts performance evaluations of subordinates and recommends pertinent development plans. 
• Provides guidance and direction to the extrusion technicians.
• Lead project timelines for Validation (IQ/OQ/PQ) activities.
• Deliver extrusion processes solutions that meet expectations, e.g., yield, cycle-time, quality requirements, maintenance needs.
• Performs statistical analysis of extrusion processes.
• Design, propose and/or implement improvements. 
• Contribute to the achievement of organizational metrics.
• Monitoring of the extrusion areas directly, attending administrative meeting projects and review of metrics, etc.
• Own and complete CAPA tasks and deliverables (Corrective and Preventive).
• Proficiency with the use of SPC, DOE and Six Sigma techniques.
• Be able to independently lead a team navigating through hurdles, achieve performance, consider input from multiple functional areas & address the problem through a holistic method.
• Parts cost analysis and justification for the purchase of new equipment.
• Ownership of purchase orders process for materials and equipment’s in assigned projects.
• Apply the policies and procedures of the ISO 13485 Quality Systems, Environmental Management System (ISO 14001), Health and Hygiene and Occupational Safety Management System (OHSAS 18001) and any other system that the company requires for its operation. 

Knowledge & Skills

• Knowledge of extrusion manufacturing of single and multi-lumen processes and their capabilities.
• Demonstrated expertise in design, selection, troubleshooting, and optimization of extrusion screws, dies, and mandrels.
• Experience with online (Zumbach) or offline (Mitutoyo, Keyence, Micro-Vu) measuring devices.
• Proficient in Solid works or similar.
• Demonstrate problem analysis skills and provide solutions.
• Review and understand single and multi-lumen, product drawings, tolerance, and understanding extrusion processing documents, data collection and analysis and development of standard work instructions. Have a knowledge of Extrusion resin types and processes, and equipment. 

Minimum Qualifications, Education & Experience 

• Must be at least 18 years of age
• Bachelor’s degree in industrial, Electronics, Electrical, Mechanical, or Chemical Engineering preferred; equivalent relevant experience may be considered in lieu of a degree.
• 7+ experience in the practical area of extrusion.
• Medical Devices experience is a plus. 
• Proficiency in the English Language, both spoken and written.
• Solid Works 
• Mini Tab
• Microsoft Office 
• Statistical process control (SPC); capacity, verification, and validation of the process; metrology; inspection techniques; reliability statistics, sampling plans.
• Work with integrity and build trust.
• Problem solving and analysis skills.
• Review and interpret technical documentation.
• Work precisely with attention to detail.

Work Environment

• While performing the duties of this job, the employee may be required to sit, stand, and walk for extended periods of time.
• Typically requires travel 20-50% of the time

ICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.

With the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.

We're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:

• Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization.
• The industry’s broadest IV smart pump offering covering large volume, pain management, and ambulatory needs.
• IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company.
• Significant US IV solutions manufacturing and supply capabilities.

ICU Medical EEO Statement:

ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status. 

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at humanresources@icumed.com. We are committed to providing equal access and opportunities for all candidates.