Mold Validation Engineer at Minneapolis, MN (Onsite)
BN Associates Inc. · Minnesota, United States · 2 wk ago
Quality AssuranceFull-time
Onsite position in Minneapolis, MN. Hands-on experience in Mold Validation within the Medical Device industry required.
Requirements
- Bachelor’s or Master’s degree in Mechanical Engineering, Polymer Engineering, Industrial Engineering, Production Engineering, or related field
- 8–12 years of relevant experience
- Experience with Medtronic, Abbott, Boston Scientific, BD, Stryker, Baxter, or Cardinal Health
Responsibilities
- Execute mold trials (Functional Test, Gate Freeze, D3, Characterization)
- Capture RJG data and define validated process windows
- Update PODs and FW redlines
- Prepare draft OQ/PQ plans
- Coordinate daily with Medtronic ME, Operations, Quality, and Tooling teams
- Approve POD redlines and validation documents
- Ensure compliance with QMS and regulatory standards
- Run trials, collect RJG data, and set process windows
- Prepare PODs, FW redlines, and OQ/PQ drafts
- Define mold validation scope
- Approve validation approach, parameters, and 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 OQ/PQ draft documents
- Provide sign-off on validation readiness
Skills
- Mold qualification expertise