Mold Validation Engineer
katalyst healthcares life sciencesMinneapolis, MN
Mold Validation Engineer
L5
katalyst healthcares life sciencesMinneapolis, MN16 days ago
Industries
Industrial Mold ManufacturingSurgical Appliance and Supplies ManufacturingAll Other Plastics Product ManufacturingJob-ID32857021 Reference 26-01457 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.
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Level
SeniorL5
Location
Minneapolis, MN
Occupation
Validation Engineers
Industry
Industrial Mold Manufacturing
Posted
16 days ago
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