Senior Technician, Process

ICU Medical•Salt Lake City, UT

3d•Onsite

About The Position

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.

Requirements

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.
High school diploma or equivalent required.
Minimum of 7+ years of extrusion manufacturing experience, including process setup, optimization, troubleshooting, and validation activities.
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.
Ability to support new product introductions, process transfers, and continuous improvement projects.
Ability to read, write, and communicate effectively in English.

Nice To Haves

Associate degree or technical certification in Mechanical Engineering, Electromechanical Technology, Plastics Technology, or a related field preferred.
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.
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.

Responsibilities

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.