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Mechanical Design Engineer

Katalyst Healthcares & Life Sciences

Denver, CO

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JOB DETAILS
SKILLS
3D Modeling, Contract Manufacturing, Design Services, Design Verification, FDA (Food and Drug Administration), FDA Requirements, File Maintenance, ISO (International Organization for Standardization), Maintain Compliance, Manufacturing Design, Mechanical Design, Mechanical Engineering, Medical Equipment, Product Development, Product Support, Proof of Concept, Prototyping, Regulatory Compliance, SolidWorks, Technical/Engineering Design, Testing, Validation Testing, Writing Skills
LOCATION
Denver, CO
POSTED
30+ days ago
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:
  • bachelor's degree in mechanical engineering
  • Minimum of 2+ years of mechanical design experience, preferably in medical devices within a regulated environment
  • Proficiency in SolidWorks
  • Working knowledge of ISO and FDA design controls
  • Experience supporting new product development from concept through testing and validation

About the Company

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Katalyst Healthcares & Life Sciences