Description and details of activities * Assist in the development of tool concepts and cost estimates, and evaluate multiple tool alternatives to meet customer needs and new projects. * Specify, obtain, and implement (both internally and externally) new tooling projects within the company. * Collaborate with other departments and/or sub-suppliers during the design, construction, and sampling of injection tooling projects. * Perform engineering changes on mold tools based on CAD/drawings. * Work with customers as needed throughout each stage of tool development to keep them engaged and informed. * Familiarity with all aspects of product development phases, including IQ/OQ/PQ. * Familiarity with all aspects of quality control outputs for parts, including FAI, capability studies, measurement system R&R, CAPA. * Demonstrated flexibility to manage multiple projects and interact with teams. * Coordinate and document internal and external activities for all mold improvement plans. * Work with planners, process engineers, and quality engineers to requalify molds after major mold repairs. * Collaborate with tool engineers, process engineers, and quality engineers to improve the performance and consistency of injection molds and molded components. Experience and requirements * 3 to 5 years of experience in a similar position with hands-on experience in specification, acquisition, qualification, maintenance, and repair of molds for injection-molded components. * Knowledge coordinating mold development projects with external suppliers. * Knowledge of suppliers dedicated to the design and manufacturing of plastic and silicone injection molds. * Experience in a medical device company. * Proficiency in SolidWorks software. * Electrical/mechanical knowledge. * Basic GD&T drawing interpretation skills. * Basic Microsoft Office suite (Outlook, Word, Excel, PowerPoint). * Advanced English (written/spoken). * Knowledge of preventive/corrective maintenance for thermoplastic and silicone molds, with experience in hot runners, cold runners, and pneumatic/hydraulic actuators. * Knowledge of ISO 14001 (preferred). * Experience in engineering, design, and fabrication of special tooling and related equipment. * Understanding of "POKA YOKE" techniques. * Advanced knowledge of CAD and machining software (ProE, Solid Works, Master Cam, etc.). * Knowledge of electricity, mechanics, hydraulics, and pneumatics. * Knowledge of plastic materials and design for manufacturability in terms of geometry and cosmetic quality. **Regulations:** * QSR (21 CFR Part 820) * ISO-13485 * NOM-241 **English**: ADVANCED ENGLISH (Conversational and written) Benefits * Transportation * Indexation plan * Uniforms * Funeral expenses * Educational support * Monthly health program **Number of vacancies** 1 **Area** Molding **Contract** Permanent **Modality** On-site **Shift** Daytime **Schedule** Full-time **Work hours*** Full time * Monday to Friday **Education** Professional degree **English** Spoken: Advanced, Written: Advanced **Travel availability** No