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Manufacturing Process Engineer

2 months ago

California, United States Intellectt Inc Full time
Job Summary

The Manufacturing Engineer will play a crucial role in designing, implementing, and improving manufacturing processes for medical devices and pharmaceutical products. This position requires a strong understanding of industry standards and regulations, including FDA, ISO 13485, and GMP.

Key Responsibilities
  • Design and optimize manufacturing processes to ensure compliance with regulatory requirements and quality standards.
  • Lead validation efforts for new equipment and processes, ensuring regulatory compliance.
  • Collaborate with cross-functional teams to ensure products meet quality and production efficiency targets.
  • Provide technical guidance and support to production teams, resolving issues related to process inefficiencies and equipment malfunctions.
  • Support the transfer of new products from R&D to full-scale manufacturing, including risk assessments and design for manufacturability.
  • Lead continuous improvement initiatives through Lean Manufacturing and Six Sigma methodologies.
  • Develop and maintain manufacturing documentation, ensuring compliance with ISO, FDA, and GMP requirements.
Requirements
  • Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or a related field.
  • Minimum of 3-5 years of experience in manufacturing engineering in the medical device and/or pharmaceutical industry.
  • Strong understanding of FDA regulations, ISO 13485, GMP, and other relevant medical device and pharmaceutical standards.
  • Proficient in equipment qualification and process validation techniques.
  • Experience with Lean Manufacturing, Six Sigma, or other continuous improvement methodologies.