Mechanical Design Engineer

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