About the Role Plastics Engineer I at Fresenius Medical Care’s Reynosa plant, Mexico. You will validate new systems and maintain the validated state of existing systems used to manufacture components, tubing, and resins in the plastics area. You may also support cost‑saving projects, process improvements, and cross‑functional validation/engineering initiatives, and coordinate, review, and evaluate the work of plastics engineering technicians. Responsibilities Lead engineering project implementations in the molding area, coordinating activities to meet schedule commitments. Maintain 100% training compliance per the applicable curriculum. Follow and ensure compliance with current GMP and documentation practices, keeping local procedures updated and compliant. Identify and verify machine/peripheral equipment manuals, drawings, and dimensional reports for protocol development. Develop and execute equipment validation protocols (IQ/OQ). Develop and execute engineering studies per task/project by defining tests that challenge physical/mechanical characteristics per specifications/drawings; document per established procedures. Support training and execution/verification of physical test methods, from method design through release. Perform and verify periodic process/equipment reviews in a timely manner and document per effective procedures. Support Engineering on implementation, innovation, new equipment development, and improvements. Reconcile material generated during engineering study and validation runs. Maintain, scan, and archive physical validation/study documentation and peripheral equipment manuals. Keep the validation list updated per current validation procedures. Support development of detailed modules/instructions for specific manufacturing process tasks. Perform annual reviews, temporary deviations, and activities related to engineering project implementation. Create Change Control Notifications (CCN) and required supporting documentation for process/support document updates. Create Document Management Change (DMC) for administrative updates and organizational chart revisions. Train Plastics and Quality personnel prior to executing validation protocols, engineering changes/module creation, and procedure changes. Qualifications Engineering degree (Industrial preferred). 2+ years of experience in IQ/OQ/PQ validation schemes. 2+ years generating, executing, and reporting engineering studies. 1+ year developing modules, engineering changes, and temporary process deviations. Medical industry experience desirable; plastics area experience desirable. 1+ year using basic measurement devices (caliper, micrometer, etc.). Continuous improvement tools experience (Ishikawa, 5 Whys, DMAIC, etc.). Strong computer skills required; SPC experience preferred. Intermediate MS Office; Minitab, Visio, Project. Bilingual (English/Spanish). Benefits & Opportunity Involved in making better medicine available to more people worldwide. Individual opportunities for self‑determined career planning and professional development. Corporate culture that encourages innovative thinking—finding the best solution together. Team of committed professionals with diverse skills, talents, and experiences. Strength of a successful global corporation combined with the collegial culture of a mid‑sized company. #J-18808-Ljbffr