Medical Device Tooling Specialist

Job Title : Tooling & Manufacturing Engineer – Medical Devices

Job Summary :

The Tooling & Manufacturing Engineer at IF MedTech will be responsible for managing and supporting the development of high-precision injection molds / dies and overseeing the batch manufacturing of plastic components for medical devices. The role involves close collaboration with internal mechanical design teams and external mold development vendors to ensure mold and part quality, manufacturability, and compliance with ISO 13485 standards. This position emphasizes Design for Injection Molding (DFIM) and manufacturing scalability to ensure 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 :

Educational Qualification :