Minimum of 2+ years in mechanical design, ideally in medical devices.
Proficient in SolidWorks CAD software.
Understanding of ISO and FDA design controls.
Experience with product development from concept to validation.
Responsibilities
Lead product development from concept to design verification for needle-free drug delivery.
Create and release 3D models and drawings using SolidWorks.
Maintain Design History Files and support regulatory audits.
Ensure compliance with ISO and FDA design control standards.
Collaborate with manufacturers to optimize designs for production.
Manage prototypes and iterate designs based on testing and vendor feedback.
Full Job Description
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
uthor 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
