Process Engineer

The Process Engineer is responsible for leading and sustaining process improvement initiatives across the Cartago plant, focusing on value stream optimization, operational excellence (ProTrack), customer satisfaction, and cost efficiency. This role actively supports manufacturing operations, Quality, and Kaizen events to ensure standardized practices aligned with other Tekni-Plex Tubing plants (COI, Clayton, and Mexicali). The Process Engineer leads problem-solving and root cause analysis related to product performance, customer complaints, and process deviations, implementing effective corrective and preventive actions. The position also participates in Level Zero and capacity improvement projects, ensuring alignment with site and global strategic prioritiesDuties and Responsibilities.ProTrack / Operational Excellence:Lead and sustain ProTrack (OPEX) projects in Cartago, ensuring proper documentation, savings validation, and standardization of improvement initiatives.Support continuous improvement events (Kaizen, waste elimination, setup reduction) and ensure timely project closure in ProTrack.Quality & Customer Complaint SupportCollaborate with the Quality team to perform root cause analysis (RCA) and implement corrective/preventive actions (CAPA) related to customer complaints or process deviations.Provide technical input for investigations that require extrusion process expertise.Process & Tooling Development:Design and validate fixtures, tooling, and process improvements to increase throughput, repeatability, and equipment reliability.Coordinate validation and documentation updates (IQ, OQ, PQ) associated with new or modified tooling and processes.Lead and manage Level Zero projects for the Cartago plant, ensuring alignment with strategic capacity initiatives, validation requirements, and standardization objectives across the tubing network.Develop and maintain engineering documentation, technical drawings, and process parameters to support traceability and continuous improvement efforts.Collaborate with Maintenance and Production to identify and implement technical solutions that enhance equipment uptime and process stability.Training & Standardization:Develop and maintain process standard work instructions, setup guides, and visual controls to ensure consistency across shifts and with other tubing sites.Conduct or support technical training sessions for operators, QA, and process technicians.Cross-functional Coordination:Serve as a technical liaison between production, maintenance, and quality during troubleshooting or product transitions.Ensure communication and alignment with engineering teams in COI, Clayton, and Mexicali to maintain global process standards.QualificationsA bachelor's degree in industrial, Materials, Mechanical or related Engineering field with at least 5 years of experience in a regulated manufacturing environment, preferably within the medical device industry.Proven experience in extrusion or injection molding, process improvement, and medical-grade manufacturing processes.Solid understanding of ISO 13485:2016 Quality Management Systems and FDA 21 CFR Part 820 regulations, ensuring compliance during process design, validation, and change control activities.Experience in Operational Excellence programs (Lean, Six Sigma) and in customer complaint investigation and root cause analysis is highly preferred.Familiarity with capacity planning and SIOP processes is a plus.Excellent Spanish English communication skills, both verbal and written.