The Medical Device Software Engineer is a senior software engineering role to be a principal developer of FDA regulated software as a medical device.
- Software analysis, planning, design, implementation, and verification of novel medical devices that consist of medical image processing
- Contribute to product requirement development and risk management reviews
- Design and code medical-grade software that meets the defined software requirements and Design Inputs
- Work collaboratively with researchers and application development engineers in all software development phases
- Work effectively in cross-functional teams consisting of Research, Engineering, QA/RA, and Marketing
- Report progress regularly to Management
- Create documentation adhering to quality procedures, regulations, standards and industry best practices under Design Control