Mold Validation Engineer
Grand Rapids, MI
Contract role
The Mold Validation Engineer is responsible for planning, executing, and documenting injection mold validations to establish robust, compliant, and transferable manufacturing processes in accordance with Medical Device Quality System requirements and applicable regulations (FDA QSR, ISO 13485). This role is primarily accountable for mold qualification, scientific molding, process characterization, and IQ/OQ/PQ execution, ensuring molds are production ready and capable of supporting ramp up and sustained manufacturing.
Key Responsibilities:
• Lead end to end mold validation execution, including POD, IQ, OQ, and PQ planning and execution.
• Develop and execute mold qualification sequences (T0–T1, T1’, OQ, PQ).
• Author and maintain POD, OQ, and PQ protocols, reports, and validation documentation.
• Plan and execute mold functional testing, screening runs, and sampling.
• Conduct gate freeze studies and establish scientific molding set points and process windows.
• Perform process characterization using DOE and RJG scientific molding.
• Establish and document RJG settings, cavity pressure signatures, and control limits.
• Troubleshoot molding, tooling, or material issues identified during validation trials.
• Execute First Article Inspection (FAI) and ensure CTQ conformance.
• Execute Operational Qualification (OQ) and Performance Qualification (PQ) runs and reporting.
• Update and redline Production Operating Documents (PODs) and Factory Works documentation.
• Support validation related activities for PFMEA, Control Plans, and process documentation.
• Act as the technical lead during mold validation activities, coordinating with Manufacturing, Quality, Tooling, Metrology, and suppliers.
• Provide clear status updates, risk identification, and validation conclusions to stakeholders.
Qualifications:
• Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Plastics Engineering, or related discipline.
• 6–8 years of hands on experience in injection molding mold validation and process development.
• 1–2 years of experience in a regulated industry (Medical Device or Pharma).
• Proven experience executing IQ/OQ/PQ validations in a regulated environment.
• Strong working knowledge of RJG scientific molding, cavity pressure analysis, and process window development.
• Experience with gate freeze studies, DOE, and process capability analysis (Cpk/Ppk).
• Ability to interpret part drawings, mold designs, CTQs, and tolerances.
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