Staff Software Test Engineer, Medical Devices jobs in United States
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SandboxAQ · 1 month ago

Staff Software Test Engineer, Medical Devices

SandboxAQ is a high-growth company delivering AI solutions that address some of the world's greatest challenges. They are seeking a highly experienced Software Quality Test Engineer to take ownership of the software testing lifecycle for a next-generation cardiac diagnostic device. This role involves creating comprehensive test plans, executing testing work, and generating reports for FDA regulatory filing, while ensuring compliance with medical device standards.

Artificial Intelligence (AI)Cyber SecurityInformation TechnologyQuantum ComputingSaaS
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H1B Sponsor Likelynote

Responsibilities

Develop, write, and own clear and comprehensive software test plans, protocols, and procedures for a complex medical device system, ensuring full traceability to software requirements, at FDA’s “enhanced SW documentation level”
Drive the hands-on V&V effort by writing and integrating tests at multiple levels: unit tests directly into the C/C++ firmware and Python backend codebases, component tests for our React applications, and automated system-level tests
Design and execute comprehensive manual system-level and integration test protocols, particularly for scenarios involving real-world hardware interactions
Provide input into the requirements definition process to ensure all software requirements are clear, concise, and verifiable
Collaborate on a range of quality system documents, such as risk management files (e.g., swFMEA) and traceability matrices, to support the overall submission
Ensure all software testing activities and documentation comply with medical device standards (e.g., IEC 62304) and our internal Quality Management System (QMS)
Proactively provide product quality feedback to Engineering and help drive root cause/fix to improve user satisfaction and user experience
Voice of Quality for the Software team to influence software development to be compliant with applicable software development standards for medical devices
Own identification, qualification and maintenance of relevant software development and V&V tools per SandboxAQ’s Quality Management System (QMS)

Qualification

Software V&V experienceC/C++ programmingPython programmingMedical device standardsTest automation frameworksCI/CD pipelinesTest management toolsProactive mentalityAttention to detailCommunication

Required

B.S. in Computer Science, Electrical Engineering, or a related technical field
7+ years of experience in a software quality or testing role, with a significant portion spent in the medical device industry
Strong programming proficiency, with demonstrated experience writing unit tests in both C/C++ and Python
Demonstrated, hands-on experience authoring and executing software V&V test plans and reports for a 510(k) medical device submission (both SiMD and SaMD)
Deep understanding of medical device software development lifecycles and standards, particularly IEC 62304
Experience testing complex, multi-component systems that include firmware, software, and cloud elements
Authorization to work in the United States

Preferred

Hands-on experience with modern test automation frameworks and tools, specifically playwright, pytest and storybook
Experience with CI/CD pipelines, particularly GitHub Actions
Familiarity with device fleet management and configuration tools like Ansible and Mender
Proficiency with test management and QMS tools
Previous experience with diagnostic or cardiology devices

Benefits

Competitive salaries
Stock options depending on employment type
Generous learning opportunities
Medical/dental/vision
Family planning/fertility
PTO (summer and winter breaks)
Financial wellness resources
401(k) plans
And more.

Company

SandboxAQ

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SandboxAQ develops AI and quantum technology solutions that enhance biopharma, cybersecurity, and materials science.

H1B Sponsorship

SandboxAQ has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (6)
2023 (3)
2022 (5)
2021 (1)
2020 (5)

Funding

Current Stage
Late Stage
Total Funding
$975M
Key Investors
Eric Schmidt Angel InvestmentsMichael J. Fox Foundation
2025-04-04Series E· $150M
2024-12-18Series E· $300M
2024-10-29Grant· $25M

Leadership Team

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Jack Hidary
Chief Executive Officer
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Joerg Rathenberg
Head Of Marketing
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Company data provided by crunchbase