Mold Validation Engineer
Full-time
Purple Hires Inc
JOB DESCRIPTION Job Summary
- Seeking an experienced Mold Validation Engineer with strong hands-on mold validation experience in the medical-device industry .
- The engineer will execute mold trials, analyze molding/process data, establish validated process windows, and prepare/approve validation documentation.
- The ideal candidate should understand injection molding, mold qualification, RJG data, process validation, OQ/PQ and regulated medical-device manufacturing .
- Strong collaboration with Manufacturing Engineering, Operations, Quality and Tooling teams is required. Key Responsibilities
- Execute mold trials including:
- Functional Testing
- Gate Freeze
- D3
- Characterization
- Collect and analyze RJG data .
- Establish and document validated process windows.
- Prepare and update PODs and FW redlines .
- Prepare draft OQ/PQ plans and validation documentation .
- Define mold validation scope and validation requirements.
- Review mold trial results and recommend process changes when required.
- Coordinate daily with Manufacturing Engineering, Operations, Quality and Tooling teams.
- Coordinate press allocation and trial schedules.
- Review trial results and participate in technical decisions.
- Approve POD redlines.
- Review and approve OQ/PQ draft documents.
- Provide validation templates and documentation formats.
- Confirm validation readiness and provide required sign-off.
- Ensure molding processes comply with applicable QMS and regulatory requirements .
- 8 12 years of relevant engineering experience .
- Strong hands-on mold validation / mold qualification experience .
- Direct experience in the medical-device industry is highly preferred/required for sourcing .
- Strong injection molding / plastic molding background.
- Experience collecting and using RJG/process data .
- Experience defining process windows .
- Experience with OQ/PQ and process validation .
- Experience preparing validation documentation.
- Engineering degree in:
- Mechanical Engineering
- Polymer Engineering
- Industrial Engineering
- Production Engineering
- Plastics/related engineering discipline
- Ability to work onsite in Minneapolis, MN .
Vacancy posted 1 day ago
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