Molding Process Engineer

Position Title: Molding Process Engineer

Location: Irvine, CA

Duration: 24 Months

Job Description

The Molding Process Engineer is responsible for developing, maintaining, and optimizing all injection molding processes at Viant Medical. This role involves interaction with various departments and customers to ensure proper execution of qualification activities, as well as supporting production through mentoring and training process technicians.

Key Responsibilities

• Develop robust and consistent molding processes using scientific molding techniques.
• Propose and implement modifications to molds, equipment, and processes to increase productivity and efficiency.
• Troubleshoot issues related to molding, secondary operations, and materials.
• Collaborate with internal and external resources to resolve molding and manufacturing issues, implementing long-term solutions.
• Create and execute validation protocols (IQ/OQ/PQ) in compliance with FDA and ISO regulations, ensuring timely updates to customers.
• Design and execute Design of Experiments (DOEs) to optimize process performance.
• Optimize process performance through instrumented monitoring (e.g., RJG EDart-CoPilot).
• Create operating procedures and instructions to standardize production, and provide training to Process Technicians and production personnel.
• Identify and propose cost reduction projects and process improvements.
• Provide technical assistance and support to Process Technicians, including troubleshooting, root cause analysis, and repair/modification of tooling and processes.
• Create and maintain Bills of Materials (BOMs) and routings through Engineering Change Orders (ECO) and Corrective Action Reports (CAR).
  
  

Qualifications

• Bachelor’s degree in Engineering (Industrial, Manufacturing, Electro-Mechanical, or equivalent).
• Minimum of 8 years of hands-on experience in injection molding.
• Deep knowledge of Scientific Molding.
• Experience with a variety of engineering resins.
• Proficiency in MS Office tools (Word, Excel, PowerPoint, Project).
• Experience with CAD Software (SolidWorks, AutoCAD, Mold Flow).
• Proficiency in Data Analysis (Minitab).
• RJG Master Molder certification is highly desirable.
  
  

Requirements, Skills, And Experience

• Strong analytical and problem-solving skills.
• Experience working in an FDA and ISO regulated environment.
• Qualification in Secondary Operations.
• MRP experience, IQMS or similar.
• Self-motivated with the ability to work with minimal supervision.
• Familiarity with Microsoft Office, Minitab, Project, and AutoCAD software.