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Industrial Engineer

Indianapolis, IN

Industrial Engineer

We are seeking an Industrial Engineer to support manufacturing and process improvement in the medical device industry. This role is responsible for optimizing workflows, ensuring compliance with FDA/ISO 13485 standards, and driving efficiency across production.

Responsibilities

  • Design and improve manufacturing processes for medical devices.

  • Conduct time studies, capacity analysis, and workflow optimization.

  • Support new product introductions and scale-up activities.

  • Collaborate with Quality, R&D, and Manufacturing on process validation.

  • Apply Lean/Six Sigma tools to drive continuous improvement.

  • Ensure compliance with GMP, ISO 13485, and FDA requirements.

Qualifications

  • 2+ years of industrial or manufacturing engineering experience, preferably in medical devices or other regulated industries.

  • Strong background in Lean Manufacturing and process optimization.

  • Knowledge of FDA, ISO 13485, and GMP standards.

  • Strong analytical, communication, and problem-solving skills.

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