Staff Software Test Engineer, Medical Devices

📋 Description

• • SandboxAQ is at the forefront of innovation, delivering cutting-edge AI solutions that tackle some of the world's most significant challenges. Our Large Quantitative Models (LQMs) are driving breakthroughs across vital sectors including life sciences, financial services, navigation, and cybersecurity. We are a dynamic, global team comprised of experts spanning AI, chemistry, cybersecurity, physics, mathematics, medicine, engineering, and a multitude of other specialized fields. Emerging as an independent entity from Alphabet Inc. in 2022, SandboxAQ is backed by leading investors and a distinguished braintrust of industry leaders, positioning us for high growth and transformative impact.
• • At SandboxAQ, we foster an environment that champions creativity, encourages deep collaboration, and prioritizes tangible impact. Our commitment to investing in our people is the bedrock of our thriving, global workforce, equipping us to address the world's most complex challenges. We invite you to advance your career with us, pursuing an inspiring mission within a community of like-minded individuals who embody entrepreneurial spirit, embrace ownership, and are driven by the pursuit of transformative change.
• • *The Opportunity: AQMed - Revolutionizing Cardiac Diagnostics**
• • The AQMed division is dedicated to developing a next-generation, non-invasive cardiac diagnostic device poised to redefine how heart health is assessed. This role operates at the critical intersection of regulated medical device development and the agile, fast-paced environment of startup innovation, with an unwavering emphasis on quality, scientific rigor, and paramount patient safety. SandboxAQ is actively seeking a highly experienced Staff Software Test Engineer, Medical Devices to spearhead our software verification and validation (V&V) efforts for a novel medical device. This pivotal role is central to ensuring our software not only meets stringent FDA regulatory requirements but also supports rapid, high-quality product development cycles.
• • *Your Impact and Responsibilities:**
• • **Lead End-to-End Software Testing:** You will own the entire software testing lifecycle, from initial planning through execution and final reporting. This includes authoring and meticulously maintaining comprehensive software test plans, detailed test protocols, and robust test reports. Crucially, you will ensure full traceability of all testing activities to software requirements, adhering to the FDA's enhanced software documentation standards.
• • **Hands-On Verification & Validation:** This role demands significant hands-on engagement. You will be responsible for designing, writing, and executing a wide array of tests across multiple software layers. This includes testing C/C++ firmware, Python-based backend services, React-based front-end applications, and comprehensive automated system-level testing.
• • **System-Level and Integration Testing:** You will design and execute manual system-level and integration tests, with a particular focus on validating real-world hardware-software interaction scenarios. This ensures the device functions seamlessly and reliably in its intended operational environment.
• • **Collaborate for Quality:** You will serve as the "Voice of Quality" for software, fostering strong partnerships with the Engineering, Quality Assurance, and Regulatory Affairs teams. Your collaboration will ensure software requirements are clearly defined, inherently testable, and fully aligned with regulatory expectations and patient safety standards.
• • **Contribute to Quality System Documentation:** You will actively contribute to the development and maintenance of our Quality Management System (QMS) documentation. This includes creating and updating risk management artifacts, such as software Failure Mode and Effects Analysis (FMEA), generating comprehensive traceability matrices, and participating in tool qualification processes, all in strict accordance with ISO 13485 and other relevant standards.
• • **Drive Test Automation Strategy:** You will play a key role in defining and implementing our test automation strategy, identifying opportunities to enhance efficiency and coverage through the use of modern testing tools and frameworks.
• • **Support Regulatory Submissions:** Your meticulous documentation and rigorous testing will directly support our FDA 510(k) submission process, ensuring all software V&V evidence is submission-ready and meets the highest standards of compliance.
• • **Champion Best Practices:** You will advocate for and implement software testing best practices throughout the development lifecycle, promoting a culture of quality and continuous improvement within the engineering teams.
• • **Troubleshoot and Debug:** You will actively participate in identifying, troubleshooting, and resolving software defects, working collaboratively with development teams to ensure timely and effective solutions.
• • **Understand the User and Patient:** You will maintain a deep understanding of the intended use of the medical device and the needs of the end-users and patients, ensuring that testing directly reflects these critical considerations.
• • This role is integral to the success of AQMed's mission to bring a life-changing cardiac diagnostic device to market. You will have the unique opportunity to shape the quality and compliance strategy for a groundbreaking medical product from its early stages.