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Manufacturing Process Engineer

2 months ago

Fremont, California, United States Intellectt Inc Full time
About the Role

At Intellectt Inc, we are seeking a highly skilled Process Optimization Specialist to join our team. As a key member of our manufacturing team, you will be responsible for developing, optimizing, and maintaining injection molding processes to ensure they meet FDA and ISO regulations.

Key Responsibilities
  • Process Development: Develop and refine molding processes using scientific molding techniques to improve productivity and efficiency.
  • Equipment Optimization: Implement modifications to molds and equipment to enhance productivity and efficiency.
  • Troubleshooting: Troubleshoot and resolve molding and material issues to minimize downtime and ensure quality.
  • Validation and Compliance: Execute validation protocols (IQ/OQ/PQ) under FDA and ISO guidelines to ensure regulatory compliance.
  • Process Improvement: Design and execute Design of Experiments (DOEs) to optimize process performance and identify cost reduction opportunities.
  • Training and Development: Create operating procedures and provide training to production staff to ensure knowledge transfer and process consistency.
  • Collaboration: Support Process Techs with troubleshooting and process modifications to ensure seamless communication and collaboration.
Requirements
  • Education: Bachelor's degree in Engineering (Industrial, Manufacturing, Electro-Mechanical, or equivalent).
  • Experience: 10+ years of hands-on experience in molding processes, with expertise in scientific molding and a variety of engineering resins.
  • Skills: Strong analytical and problem-solving skills, with experience in MS Office tools, CAD Software (SolidWorks, AutoCAD), and Data Analysis (Minitab).
  • Certifications: RJG Master Molder certification preferred but not required.
  • Regulatory Experience: Experience in FDA and ISO regulated environments, with medical device experience a must.
  • MRP Systems: Familiarity with MRP systems (e.g., IQMS).