Mold Validation Engineer

Primary Responsibilities

• Executes mold trials (Functional Test, Gate Freeze, D3, Characterization)
• Captures RJG data & defines validated process windows
• Updates PODs & FW redlines
• Prepares draft OQ/PQ plans
• Coordinates daily with Healthcare ME, Ops, Quality, and Tooling
• Approves POD redlines & validation documents
• Ensures compliance with QMS & regulatory standards
• Run trials, collect RJG data, set process windows
• Prepare PODs, FW redlines, OQ/PQ drafts
• Coordinate with Healthcare teams
• Define mold validation scope
• Approve validation approach, parameters, PODs
• Provide templates (OQ, PQ, FW forms, POD format)
• Confirm press allocation and trial windows
• Review all trial results
• Participate in technical decisions (e.g., process window changes)
• Approve POD redlines
• Approve OQ/PQ draft documents
• Provide sign-off on validation readiness

Qualification

• Mold engineer -Mold qualification skills required.
• BE/master's in relevant to mechanical/Polymer/Industrial /Production .
• Exp range: 8 -12 years

Please look for hands on experience in Mold Validation role in Medical Device Industries.

• Healthcare.
• Client.
• Boston Scientific.
• Client.
• Stryker.
• Baxter.
• Cardinal Health.