Mold Validation Engineer - Medical Device Process Windows

JobDiva, Inc.; Minneapolis (MN); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

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.

Formación

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

Responsabilidades

• 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.

Conocimientos

Mold qualification skills

Mold validation experience

Educación

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

Descripción del empleo

Primary Responsibilities:

• 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
• 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 Healthcare 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

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.