Careers With Sonablate
Senior Software Engineer
The Senior Software Engineer is responsible for the entire software lifecycle, from early concept discussions with the clinical staff to through final testing and software maintenance.
Duties and Responsibilities
- Design, develop and test HIFU treatment software.
- Design, develop and test graphical user interface (GUI) software.
- Design, develop and test probe motion control software.
- Develop and maintain non-product software used in the performance tests during the manufacturing process.
- Assist Electrical Engineers with design and testing of custom electronics.
- Assist Technicians with system integration and troubleshooting.
- Develop and maintain software documentation.
- Assist technicians and distributors with field support.
- All other duties, as assigned.
- Bachelor’s degree in Computer Science, required.
- Excellent communications skills, both oral and written, required.
- Experience on hardware/software development teams, required.
- Experience with Java, C++, and Windows Environments, required.
- Experience with international standards for quality systems, required.
- Minimum of 10 years related experience, required.
- Understanding of software development process within a medical device manufacturing environment including general knowledge of Good Manufacturing Practices, Good Engineering Practices, FDA Quality System Regulation, ISO 13485, Healthcare compliance and applicable regulations and industry standards regarding clinical research and regulation of medical devices.
- General knowledge of IEC 62304 Medical Device Software –Software Life Cycle Processes, FDA General Principles of Software Validation Final Guidance for Industry and Staff, FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- OpenGL experience (3D modeling), preferred.
- JNI experience, preferred.
- Experience with hardware control and general digital/analog I/O, preferred.
Welcome to an established company, with a proven product, and a start-up feel. Sonablate Corp. was created following an acquisition of SonaCare Medical, LLC in 2021. We have designed, developed, manufactured, sold, and serviced the Sonablate HIFU ablation device for over two decades, receiving 510K de novo clearance with the FDA in 2015. The Sonablate device is cleared in more than 50 countries, including a CE Marking in the European Union and approval from the National Medical Products Administration in China.