Mold Validation Engineer

Katalyst HealthCares and Life Sciences

• $95K — $115K *
Minneapolis, MN 55407In-Person
Healthcare
8 - 10 years of experience
Today
Be an Early Applicant
Job Overview by Ladders

Qualifications

  • Mold engineering expertise with a focus on mold qualification.
  • Bachelor's or Master's degree in mechanical, polymer, industrial, or production engineering.
  • 8-12 years of hands-on experience in mold validation, particularly in the medical device sector.

Responsibilities

  • Execute mold trials including functional tests and characterization.
  • Capture RJG data and define validated process windows.
  • Update PODs and FW redlines as needed.
  • Prepare draft OQ/PQ plans for validation processes.
  • Coordinate daily with healthcare teams, ops, quality, and tooling departments.
  • Review and approve POD redlines and validation documents.
  • Ensure compliance with Quality Management System (QMS) and regulatory standards.

Benefits

  • Opportunities for professional development and skill enhancement.
  • Collaboration with leading healthcare clients and industry professionals.
  • Exposure to advanced technology and methodologies in mold validation.
  • A supportive work environment fostering teamwork and innovation.
Full Job Description
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
  • pproves 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
  • pprove 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)
  • pprove POD redlines
  • pprove 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.
* Ladders Estimates

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