Senior Technician, Process

Job Summary

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.