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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