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:
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