KH
Mechanical Design Engineer
Katalyst Healthcares & Life Sciences
🇺🇸 United States
On-site
5 months ago
- SolidWorks
- Regulatory Compliance
5 months ago
Not enough detail in this posting to match
- 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
Mechanical Design Engineer · Katalyst Healthcares & Life Sciences