Mechanical Design Engineer

Katalyst Healthcares & Life Sciences

Full-time other-general
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Location
Denver, Colorado, United States
Posted
May 16, 2026

Job Description

Roles & Responsibilities:

  • Lead new product development from proof-of-concept through design verification for a needle-free drug delivery application, following a stage-gate NPD process

  • Create, refine, and release 3D models and production drawings for disposable and syringe-based components using SolidWorks

  • Author and maintain Design History Files (DHF) and support audits, inspections, and regulatory compliance activities

  • Ensure adherence to ISO and FDA design control requirements throughout the development process

  • Optimize designs for manufacturability and scale-up in collaboration with contract manufacturers and key suppliers

  • Manage prototype builds, testing iterations, and design refinements through vendor engagement and validation activities


Education & Experience:


  • bachelo...