What are the responsibilities and job description for the Validation Engineer position at ITMC Systems, Inc?
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