Mold Validation Engineer

Minneapolis, MN, US • Posted 2 days ago • Updated 3 hours ago
Full Time
On-site
Fitment

Dice Job Match Score™

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Job Details

Skills

  • Functional Testing
  • D3.js
  • Regulatory Compliance
  • QMS
  • Forms
  • Microsoft Windows
  • OQ
  • PQ
  • Mechanical Engineering
  • Medical Devices
  • Health Care

Summary

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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 91116760
  • Position Id: 1325da9aaee660fbec0af91e30b50149
  • Posted 2 days ago
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