Validation Engineer
Mold Validation Engineer (531645)Minneapolis, MN (Onsite)Please look for hands on experience in Mold Validation role in Medical Device Industries..Educational background : BE/master’s in relevant to mechanical/Polymer/Industrial /Production.Exp range 8-12 yearsMedtronicAbbottBoston ScientificBDStrykerBaxterCardinal HealthJob Description & Skill Requirement:Executes mold trials (Functional Test, Gate Freeze, D3, Characterization)Captures RJG data & defines validated process windowsUpdates PODs & FW redlinesPrepares draft OQ/PQ plansCoordinates daily with Medtronic ME, Ops, Quality, and ToolingApproves POD redlines & validation documentsEnsures compliance with QMS & regulatory standardsRun trials, collect RJG data, set process windowsPrepare PODs, FW redlines, OQ/PQ draftsCoordinate with Medtronic teamsDefine mold validation scopeApprove validation approach, parameters, PODsProvide templates (OQ, PQ, FW forms, POD format)Confirm press allocation and trial windowsReview all trial resultsParticipate in technical decisions (e.g., process window changes)Approve POD redlinesApprove OQ/PQ draft documentsProvide sign-off on validation readiness Qualification:Mold engineer -Mold qualification skills required