Tooling Engineer - Medical Devices

As a Tooling & Manufacturing Engineer at IF MedTech, you will play a crucial role in managing and supporting the development of high-precision injection molds/dies and overseeing the batch manufacturing of plastic components for medical devices. Your responsibilities will involve collaborating with internal mechanical design teams and external mold development vendors to ensure mold and part quality, manufacturability, and compliance with ISO 13485 standards. Your focus will be on Design for Injection Molding (DFIM) and manufacturing scalability to guarantee consistent production outcomes. Key Responsibilities: - Collaborate with mechanical design engineers to provide early input on Design for Manufacturability (DFM) and Design for Injection Molding (DFIM). - Evaluate part designs and recommend modifications for moldability, durability, and efficient manufacturing. - Manage the complete life cycle of mold/die development: from concept and vendor selection to mold trials, validation, and production readiness. - Interface with external vendors for mold/die design reviews, tooling specifications, and process validation. - Oversee batch manufacturing of molded/manufactured components at vendor sites to ensure part quality, consistency, and adherence to design intent. - Monitor and troubleshoot issues during batch production, including visual or dimensional non-conformities. - Ensure tooling and manufactured parts meet product tolerances, materials standards, and compliance with medical device regulations. - Lead mold and part validation activities including T0/T1 trials, and support IQ/OQ/PQ documentation. - Drive continuous improvement of tooling and molding processes to enhance quality and reduce cost/time. - Maintain documentation for mold designs, tooling changes, manufacturing trials, and component validation as per ISO 13485. - Collaborate with QA/RA to ensure compliance with regulatory standards for production. - Support training of internal teams on tooling technologies and injection molding processes. Required Skills and Experience: - Minimum 3 years of experience in injection molding, tooling development, and plastic part manufacturing, preferably for medical devices. - Expertise in mold design, tool validation, and troubleshooting molding defects (e.g., warpage, sink marks, flash). - Strong understanding of plastic materials, tool steels, mold flow analysis, and gating strategies. - Proficiency in CAD software (e.g., SolidWorks) for tooling review and component design analysis. - Hands-on experience with batch production of molded/casted/machined components and managing vendor performance for quality and yield. - Knowledge of IQ/OQ/PQ protocols, design history files, and manufacturing documentation under ISO 13485. - Strong communication, project coordination, and analytical problem-solving skills. Educational Qualification: - Bachelors degree in Mechanical Engineering, Tool Engineering, Plastics Engineering, or a related technical field. - Additional certifications in Injection Molding, Scientific Molding, or Tool Design are an advantage.,