An multinational medical technology company which manufactures and sells medical devices, instrument systems, and reagents.
Due to an extended period of growth, our client are in need of a number of Senior System Engineers which pre-market submission experience for medical devices.
- You will be assessing and challenging design proposals and prototypes by aggressive design reviews and comprehensive testing protocols.
- Your efforts will produce clear results by using your Requirements Management tools (DOORS, etc.) and configuration tools (TFS, etc.) experience.
- Bachelor of Engineering or Science Degree with a strong technical background within Systems Engineering, medical device development, or similar roles.
- A minimum of 7 years of Requirement Management experience within Medical Devices
- A strong understanding of preparing or working to a 510k pre-market submission for the FDA, particularly for existing products initially launched in other markets.
- Experience setting up schedules, assigning resources and managing schedules to completion.
- Excellent communication skills across departments, e.g. cross-engineering (with Electrical, Mechanical, Software, Firmware etc.) cross-functional (with Marketing, Regulatory, Clinical Representatives, Quality etc.)