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Mold Validation Engineer

Katalyst Healthcares and LifesciencesMinneapolis, MN🇺🇸United StatesPosted 17 Aug 2026

Why This Role Stands Out

This hybrid role offers a fantastic opportunity to drive critical validation processes within the reputable Katalyst Healthcares and Lifesciences, fostering significant career growth and skill development in a collaborative environment. You'll thrive here if you have a strong background in mold validation within medical devices and a keen eye for detail, contributing to impactful projects with a talented team. Apply now to leverage your expertise and advance your career in this dynamic field.

Quick Overview

Work Type
Hybrid
Level
Mid Senior

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.

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