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Mechanical Design Engineer
Katalyst Healthcares & Life Sciences • Denver, Colorado, United States
About the Role
Roles & Responsibilities:
Education & Experience:
- 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...
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