Tooling Engineer - Medical Devices

Job Title: Tooling & Manufacturing Engineer – Medical Devices

Job Summary:

Design for Injection Molding (DFIM)

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:

• Bachelor’s 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.