Molding Process Engineer

3 days ago

Fremont, United States Tek Support Full time

Position Overview:

We are seeking an experienced Molding Process Engineer III to develop, maintain, and optimize injection molding processes in a medical device environment. The ideal candidate will possess deep knowledge of scientific molding techniques, have experience working in FDA and ISO-regulated settings, and be proficient in a variety of engineering resins. An RJG Master Molder certification is preferred, though non-certified candidates with equivalent experience will also be considered.


Key Responsibilities:

  • Develop and optimize robust injection molding processes using scientific molding techniques to ensure consistent quality and efficiency.
  • Propose and implement modifications to molds, equipment, and processes to increase productivity and maximize efficiency.
  • Troubleshoot and resolve issues related to molding, secondary operations, and materials in collaboration with internal and external resources.
  • Create and execute validation protocols (IQ/OQ/PQ) under FDA and ISO regulations, ensuring compliance and keeping customers updated throughout the process.
  • Design and perform Design of Experiments (DOEs) to optimize molding process performance.
  • Utilize instrumented monitoring tools (e.g., RJG eDart-CoPilot) to enhance process performance and maintain consistency.
  • Develop and maintain standard operating procedures and work instructions to standardize production processes; provide training to process technicians and production personnel.
  • Identify, propose, and implement cost reduction projects and process improvements for molding operations.
  • Provide technical assistance and support to process technicians, utilizing systematic troubleshooting and root cause analysis methods to address and resolve day-to-day production issues.
  • Oversee the creation and maintenance of Bill of Materials (BOMs) and routings through Engineering Change Orders (ECO) and Corrective Action Requests (CAR).
  • Manage and support qualification activities for secondary operations, ensuring compliance with regulatory standards.


Qualifications:

  • Bachelor’s degree in Engineering (Industrial, Manufacturing, Electro-Mechanical, or equivalent).
  • 5+ years of hands-on experience in molding process engineering.
  • Deep expertise in scientific molding techniques and a variety of engineering resins.
  • Experience working in FDA and ISO-regulated environments, particularly within the medical device industry.
  • Proficient in CAD software (SolidWorks, AutoCAD, Mold Flow) and data analysis tools (Minitab).
  • Familiarity with MRP systems such as IQMS or similar.
  • RJG Master Molder certification (preferred but not required).

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