Mechanical Design Engineer

Job Title

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

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