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Develops, optimizes, and troubleshoots extrusion manufacturing processes while implementing statistical process controls, continuous improvement initiatives, and manufacturing procedures to improve product quality, process efficiency, and regulatory compliance. Job Requirements Bachelor's degree in Engineering. Minimum of 5 years of process engineering experience in a manufacturing environment. Hands-on experience with extrusion manufacturing processes , including equipment design, process development, and production troubleshooting. Knowledge of extrusion processes involving thermoplastics, rubber, metals, or similar materials. Experience troubleshooting extrusion lines, dies, tooling, and manufacturing process issues. Experience implementing process improvements using Six Sigma, Kanban, Kaizen, and other continuous improvement methodologies. Experience with Statistical Process Control (SPC) and Lean Manufacturing. Hands-on experience implementing SPC systems and monitoring manufacturing process performance. Experience developing and maintaining manufacturing work instructions, engineering procedures, and process documentation. Knowledge of FDA regulations and Good Manufacturing Practices (GMP). Experience supporting ISO quality audits and maintaining compliance with established quality standards. Knowledge of manufacturing process optimization, defect reduction, and process variability control. Preferred Skills Experience with extrusion processes in pharmaceutical or medical device manufacturing. Knowledge of thermoplastic or rubber extrusion equipment, dies, and tooling. Experience designing and optimizing extrusion lines and manufacturing equipment. Familiarity with

ISO 13485, ISO

9001, or other applicable quality management standards. Experience with process validation, equipment qualification, and manufacturing change control. Knowledge of Design of Experiments (DOE), process capability analysis, and root cause analysis. Experience implementing corrective and preventive actions (CAPA). Lean Six Sigma Green Belt or Black Belt certification. Experience improving extrusion throughput, dimensional consistency, material utilization, and production yield. Knowledge of regulated manufacturing documentation and quality control requirements. Job Responsibilities Develop, implement, and optimize extrusion manufacturing processes for thermoplastic, rubber, metal, or related materials. Design and improve extrusion processes, equipment configurations, and production line operating parameters. Troubleshoot extrusion equipment, dies, tooling, material flow, and process performance issues. Analyze extrusion process variables, including temperature, pressure, material feed rates, extrusion speed, and dimensional consistency. Identify and implement process improvements to reduce defects, scrap, downtime, and manufacturing costs. Develop and maintain SPC systems to monitor extrusion process performance and product quality. Analyze production data, process capability, and manufacturing trends to identify process variations and corrective actions. Lead continuous improvement initiatives using Six Sigma, Kanban, Kaizen, and Lean Manufacturing methodologies. Develop, review, and maintain manufacturing work instructions, Standard Operating Procedures (SOPs), and engineering documentation. Evaluate extrusion equipment and process changes to determine their impact on product quality and manufacturing performance. Support process validation, equipment qualification, and manufacturing change control activities as required. Investigate manufacturing defects and process deviations using root cause analysis techniques. Implement corrective and preventive actions to improve process reliability and product consistency. Coordinate process engineering activities with Manufacturing, Quality, Maintenance, and Engineering departments. Ensure extrusion processes comply with applicable FDA regulations, GMP requirements, and ISO quality standards. Prepare and maintain engineering documentation, process control records, and audit support materials. Support internal and external quality audits involving manufacturing processes and regulatory compliance. Monitor the effectiveness of implemented process improvements and update operating parameters and procedures as necessary.

Pay Details:

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable: The California Fair Chance Act Los Angeles City Fair Chance Ordinance Los Angeles County Fair Chance Ordinance for

Employers San Francisco Fair Chance Ordinance Massachusetts Candidates Only:

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.