Mechanical Design Engineer

Job TitleLead new product development from proof-of-concept through design verification for a needle-free drug delivery application, following a stage-gate NPD processCreate, refine, and release 3D models and production drawings for disposable and syringe-based components using SolidWorksAuthor and maintain Design History Files (DHF) and support audits, inspections, and regulatory compliance activitiesEnsure adherence to ISO and FDA design control requirements throughout the development processOptimize designs for manufacturability and scale-up in collaboration with contract manufacturers and key suppliersManage prototype builds, testing iterations, and design refinements through vendor engagement and validation activitiesBachelor's degree in mechanical engineeringMinimum of 2+ years of mechanical design experience, preferably in medical devices within a regulated environmentProficiency in SolidWorksWorking knowledge of ISO and FDA design controlsExperience supporting new product development from concept through testing and validation