Mold Validation Engineer - Medical Device Process Windows

Creative Solutions Services, LLC; Minneapolis (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a senior Mold Validation Engineer in Minneapolis to lead mold trials and validation efforts in medical device projects. The role focuses on defining process windows, collecting RJG data, and ensuring QMS compliance across production stages.

Ideal candidates hold a BE/Master’s in a relevant field and have 8–12 years of hands-on mold qualification experience, with hands-on ability to approve PODs, OQ/PQ drafts, and validation readiness.

Qualifications

• Mold engineer with mold qualification skills.
• BE or Master's in mechanical, polymer, industrial or production fields.
• Experience range 8-12 years.

Responsibilities

• Execute mold trials: functional test, gate freeze, D3, characterization.
• Capture RJG data and define validated process windows.
• Prepare OQ/PQ plans and POD templates.
• Coordinate daily with Healthcare ME, Ops, Quality, and Tooling.
• Review trial results and approve POD redlines and validation documents.
• Ensure compliance with QMS and regulatory standards.
• Define mold validation scope and validation approach.

Skills

Mold qualification skills

Mold validation experience

Education

BE or Master's in mechanical engineering, polymer, industrial or production

Job description

Creative Solutions Services, LLC is seeking a senior Mold Validation Engineer in Minneapolis to lead mold trials and validation efforts in medical device projects. The role focuses on defining process windows, collecting RJG data, and ensuring QMS compliance across production stages.

Ideal candidates hold a BE/Master’s in a relevant field and have 8–12 years of hands-on mold qualification experience, with hands-on ability to approve PODs, OQ/PQ drafts, and validation readiness.