Mold Validation Engineer
Minneapolis, Minnesota, United States
Job Description
Primary Responsibilities:
Qualification:
Please look for hands on experience in Mold Validation role in Medical Device Industries.
- 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
- pproves 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
- pprove 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)
- pprove POD redlines
- pprove 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.
Apply
Career Focus: Validation
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