Job Requirements
- Experience and knowledge of strength analysis and vibration analysis
- Experience in system and risk management engineering as well as design control and change control.
- Proficiency in CAD software
- Generate detailed engineering drawings, specifications, and documentation to support prototype fabrication and manufacturing processes.
- Potential design skill with with Plastic, Sheetmetal & Casting Parts
- Experience in Reverse Engineering & Value Engineering programs
- Knowledge of regulatory standards and compliance requirements for mechanical products and components.
- Experience in Rapid prototyping for functional prototype development
- Awareness of 3D Printing.
- Experience with Quality Management Systems and complying with ISO13485 and FDACFR21.820 are prefrrable
- Understanding of applicable manufacturing/testing procedures of medical devices and manufacturing processes and familiar with regulations and standards
Work Experience
Proficiency in CAD software