Mechanical Design Engineer
Katalyst CRO · Denver, CO · 2 mo ago
On-siteEngineeringContract
Roles & Responsibilities
- 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