Mold Validation Engineer at Minneapolis, MN (Onsite)

BN Associates Inc

Minnesota

Mold Validation Engineer

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 years

Medtronic
Abbott
Boston Scientific
BD
Stryker
Baxter
Cardinal Health

Job Description & Skill Requirement:

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 Medtronic 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 Medtronic 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

Apply

Vacancy posted 4 days ago

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