Job Title: Mold Validation Engineer
Location: Minneapolis, MN (Onsite)
Pay Rate: $37/hr (W2)
Work Authorization: No OPT/CPT
Job Summary
Seeking an experienced Mold Validation Engineer with strong mold qualification and validation expertise to support medical device manufacturing activities. The role will be responsible for executing mold trials, collecting and analyzing RJG process data, establishing validated process windows, preparing validation documentation, and coordinating cross-functional validation activities.
The engineer will work closely with Manufacturing Engineering, Operations, Quality, and Tooling teams to ensure all validation activities comply with QMS and regulatory requirements.
Key Responsibilities
- Execute mold validation trials, including Functional Testing, Gate Freeze Studies, D3 Studies, and Process Characterization.
- Collect and analyze RJG process data to establish validated process windows.
- Define the scope of mold validation activities.
- Prepare and update Process Output Documents (PODs) and Framework (FW) redlines.
- Develop draft Operational Qualification (OQ) and Performance Qualification (PQ) protocols.
- Coordinate daily with Manufacturing Engineering, Operations, Quality, and Tooling teams.
- Confirm press allocation and establish trial schedules.
- Review and evaluate all trial data and validation results.
- Participate in technical discussions involving process parameters and process window modifications.
- Review and approve validation approaches, process parameters, and POD documentation.
- Approve POD redlines and validation-related documentation.
- Provide final validation readiness approval and sign-off.
- Ensure all validation activities comply with Quality Management System (QMS) requirements and applicable regulatory standards.
Requirements
- Strong experience in mold qualification and mold validation.
- Hands-on experience with injection molding processes.
- Experience conducting Functional Testing, Gate Freeze Studies, D3 Studies, and Process Characterization.
- Experience using RJG systems for data collection and process monitoring.
- Experience developing and validating process windows.
- Knowledge of OQ/PQ protocol development and execution.
- Experience preparing and maintaining validation documentation.
- Knowledge of medical device manufacturing processes.
- Strong understanding of Quality Management Systems (QMS) and regulatory compliance.
- Excellent cross-functional collaboration and communication skills.
Preferred
- Experience in a regulated medical device manufacturing environment.
- Experience working with Manufacturing Engineering, Operations, Quality, and Tooling teams.
- Familiarity with POD documentation, FW forms, and validation templates.
- Experience reviewing and approving validation protocols and technical documentation.
- Strong analytical and problem-solving skills.