Manufacturing and Process Development Engineer II

4 weeks ago


Jersey City, New Jersey, United States Precision Coating Full time
Job Description

Key Responsibilities:

  • Develop and implement manufacturing processes and technologies to improve product quality, operational efficiency, and cost-effectiveness.
  • Collaborate with cross-functional teams to ensure seamless integration of new products and processes into manufacturing.
  • Design, fabricate, or source fixtures and tooling using CAD software.
  • Conduct process validation, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
  • Train manufacturing personnel in new processes and technologies.
  • Lead a culture of Continuous Improvement by applying lean manufacturing principles to streamline operations, reduce waste, and enhance productivity.

Requirements:

  • Bachelor's Degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or related field.
  • 3-6 years of hands-on professional experience in manufacturing and process development within the medical device industry (ISO 13485 or FDA regulated).
  • Familiarity with FDA regulations and ISO standards related to medical devices.
  • Technical skills in design and/or CAD experience, statistical analysis, and lean six sigma methodologies.


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