Staff Software Test Engineer, Medical Devices
Staff Software Test Engineer, Medical Devices
Staff Software Test Engineer, Medical Devices
sandboxaq
SandboxAQ is a high-growth company focused on delivering AI solutions across various sectors, including life sciences and cybersecurity. They are seeking a Software Quality Test Engineer for their AQMed division, which is developing a non-invasive cardiac diagnostic device. The role involves overseeing the software testing lifecycle, ensuring compliance with FDA regulations, and collaborating with cross-functional teams to maintain high standards of software quality.
Qualification
- Proven experience in software quality assurance and testing, particularly in medical devices.
- Strong understanding of FDA regulations and compliance processes.
- Experience in developing test plans and executing software testing.
- Ability to work collaboratively in a fast-paced, startup environment.
- Excellent communication skills to interact with cross-functional teams.
Responsibility
- Take ownership of the software testing lifecycle for a novel medical device.
- Create comprehensive test plans and execute testing work.
- Generate submission-ready reports for FDA 510(k) regulatory filing.
- Collaborate with software engineers, quality specialists, and regulatory affairs teams.
- Balance FDA compliance rigor with startup agility.
- Contribute to the broader software quality system.
