Job Summary
JOB DESCRIPTION
The objective of this position is to ensure the proper functioning and availability of extrusion machines by correctly executing preventive and corrective maintenance activities and configurations to ensure compliance with quality standards for the products processed by this equipment and adherence to all internally established criteria.
Essential Duties And Responsibilities
The functions and responsibilities mentioned in this document are illustrative but not exhaustive. Therefore, the holder of this position will perform other functions and tasks related to their work area:
- Ensure component specifications are met at each startup and coordinate sample inspections with Quality Assurance.
- Operate plastic extrusion machines and peripheral equipment, including tool changes, operational support, and equipment maintenance.
- Maintain extrusion tooling (cleaning and polishing after use) and use the tools appropriately for this maintenance.
- Ensure, through constant monitoring and in accordance with procedures, that the extruders meet production plans.
- Ensure, through constant monitoring, the optimal operation of the extruders (speed, temperatures, parameters, tooling, etc.).
- Work as a team with the production, quality, and engineering departments to guarantee the quality of the processed parts.
- Complete the documentation for the extrusion process (parameters, dimensions, results graphs).
- Adhere to the parameters as needed, within the validated window, whenever problems are found in the parts caused by natural and non-natural process variations, and report any situation that could compromise the final product.
- Work proactively with the production and engineering supervisor, as well as the line leader and quality inspector, to resolve problems in the extrusion process.
- Manage the spare parts inventory (stock) to maintain assigned equipment in optimal operating condition.
- Coordinate with the production supervisor to execute the activities necessary to meet daily production plans.
- Participate in scrap reduction projects.
- Make improvements to assigned equipment to ensure optimal operating conditions.
- Understand and apply the policies and procedures of the ISO 13485 Quality Management System, the ISO 14001 Environmental Management System, the OHSAS 18001 Occupational Health and Safety Management System, and any other system required by the company for its operation.
Knowledge And Skills
- Advanced knowledge of extrusion machinery, tooling, auxiliary equipment, and manufacturing processes.
- Extensive knowledge of handling and processing nylon, PVC, silicone, polypropylene, polyethylene, and other thermoplastic materials.
- Demonstrated expertise in analyzing, troubleshooting, and resolving extrusion process issues and product defects.
- Advanced knowledge of vacuum systems, vacuum calibration, and their impact on product quality and dimensional control.
- Expert knowledge of smooth and corrugated tube extrusion equipment, setup, operation, process optimization, and troubleshooting.
- Strong understanding of electrical, pneumatic, hydraulic, and process control systems used in extrusion manufacturing.
- Proficient in the use, calibration, and interpretation of data from online and offline measurement systems, including Zumbach, Mitutoyo, Keyence, and Micro-Vu equipment.
- Comprehensive knowledge of extrusion screw design, screw selection, material-specific screw performance, and process optimization.
- Advanced ability to develop, maintain, analyze, and interpret extrusion process documentation, including process parameters, dimensional studies, SPC charts, validation data, and process performance trends.
- Ability to establish and optimize process parameters to achieve product quality, throughput, and scrap reduction targets.
- Strong ability to interpret engineering drawings, specifications, GD&T requirements, and customer documentation.
- Proficient computer skills, including advanced use of Microsoft Excel, Word, and data collection/reporting systems.
- Ability to train, mentor, and provide technical guidance to Extrusion Technicians and Operators.
- Strong root cause analysis, problem-solving, and continuous improvement skills utilizing structured problem-solving methodologies.
Minimum Qualifications, Education, And Experience
- High school diploma or equivalent required; Associate degree or technical certification in Mechanical Engineering, Electromechanical Technology, Plastics Technology, or a related field preferred.
- Minimum of 7+ years of extrusion manufacturing experience, including process setup, optimization, troubleshooting, and validation activities.
- Minimum of 3+ years in an advanced or lead extrusion technician role preferred.
- Experience in medical device manufacturing and regulated environments (FDA, ISO 13485, GMP) strongly preferred.
- Ability to read, write, and communicate effectively in English.
- Extensive experience with extrusion machinery, downstream equipment, and peripheral systems.
- Demonstrate experience assembling, disassembling, maintaining, and troubleshooting extrusion tooling, dies, heads, calibrators, and sizing equipment.
- Proven experience conducting preventive maintenance, troubleshooting equipment failures, and supporting corrective maintenance activities.
- Experience with process validations, IQ/OQ/PQ activities, DOE studies, process development, and process capability analysis preferred.
- Experience utilizing SPC, process monitoring systems, and statistical analysis tools to drive process improvements.
- Demonstrated ability to independently lead equipment startups, product changeovers, process qualifications, and corrective action efforts.
- Ability to support new product introductions, process transfers, and continuous improvement projects.
Work Environment
- While performing the duties of this job, the employee may be required to sit, stand, and walk for extended periods of time, depending on customer needs.
- Majority of work is performed in a controlled clean room environment.
- Travel typically required less than 5% of the time.
About Us
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.
ICU Medical EEO Policy Statement
Know Your Rights: Workplace Discrimination is Illegal Poster
ICU Medical CCPA Notice to Job Applicants
