Azure Cloud Edge Test Engineer

Azure Cloud Edge Test Engineer

HistoSonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non-invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development. In addition to its current liver tumor indication, HistoSonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women's health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties.

We offer an exciting work culture where cutting-edge science meets real-world application, and each team member's contribution is important to our success in ensuring our physicians and their patients get what they need most.

Location: Plymouth, MN (Onsite)

Travel: 15%

Position Summary:

We are looking for a skilled and compliance-driven Azure Cloud Edge Test Engineer to join our medical device engineering team connecting our devices to our Azure cloud services. In this role, you will be responsible for designing, developing, and executing test strategies for cloud-edge solutions built on Microsoft Azure that power connected medical devices and clinical systems. You will work closely with software engineers, regulatory affairs specialists, DevOps teams, and product managers to ensure the reliability, performance, safety, and security of edge-computing workloads within a highly regulated healthcare environment.

Key Responsibilities:

• Design and implement comprehensive test plans, test cases, and test automation frameworks for Azure edge computing solutions supporting connected medical devices, including Azure IoT Edge and Azure Arc.
• Develop and maintain automated test suites for edge device deployments, containerized workloads, and cloud-to-device communication pipelines in compliance with applicable regulatory standards.
• Conduct functional, regression, integration, performance, and security testing across cloud-edge environments, adhering to IEC 62304 (software lifecycle), ISO 14971 (risk management), and IEC 62443 (cybersecurity) frameworks.
• Support the creation and maintenance of Design History Files (DHF), Software Development Files (SDF), and other quality system documentation required for FDA and CE submissions.
• Validate edge device provisioning, configuration management, and OTA (over-the-air) update mechanisms with full traceability to system requirements.
• Test network reliability and data integrity under adverse edge conditions, including low-bandwidth, intermittent-connectivity, and offline scenarios — with particular attention to patient safety implications.
• Design and execute test strategies for clinical web applications, including functional, cross-browser, accessibility (WCAG 2.1), and end-to-end UI testing using tools such as Ranorex, Playwright, Selenium, or Cypress.
• Validate custom Azure cloud services (REST/GraphQL APIs, microservices, serverless functions, and data pipelines) through contract testing, load testing, and fault injection to ensure correctness, resilience, and regulatory traceability.
• Test data flows end-to-end across the full stack — from edge device telemetry through cloud processing services to web application presentation layers — verifying data integrity, latency SLAs, and audit logging at each tier.
• Collaborate with Regulatory Affairs and Quality Assurance teams to ensure test activities satisfy 21 CFR Part 11, 21 CFR Part 820, and EU MDR 2017/745 requirements.
• Integrate testing into CI/CD pipelines using Azure DevOps, maintaining validated state throughout the pipeline.
• Identify, document, and track defects through to resolution, ensuring proper risk classification and impact assessment per ISO 14971.
• Perform root cause analysis on test failures and support CAPA (Corrective and Preventive Action) processes as required.
• Participate in design reviews, hazard analyses (FMEA/FMECA), and usability engineering activities related to software and edge systems.

Stay current with FDA guidance on software as a medical device (SaMD), Azure platform updates, and evolving edge computing and cybersecurity standards.

Required Qualifications:

• Bachelor's degree in Computer Science, Software Engineering, Biomedical Engineering, Electrical Engineering, or a related field (or equivalent practical experience).
• 3+ years of experience in the medical device industry and software quality assurance or test engineering, with at least 2 years focused on cloud or edge computing environments.
• Demonstrated experience working in an FDA-regulated or ISO 13485-certified medical device environment.
• Hands-on experience with Microsoft Azure services, particularly Azure IoT Hub and Azure IoT Edge.
• Familiarity with medical device software standards including IEC 62304, ISO 14971, and 21 CFR Part 820.
• Proficiency in test automation using languages/frameworks such as Python, PowerShell or Bash.
• Solid understanding of containerization technologies (Docker, Kubernetes), message bus (Service Bus) and microservices architectures.
• Experience integrating automated tests into CI/CD pipelines while maintaining a validated, audit-ready state.
• Experience testing web applications using modern frameworks (Ranorex, Playwright, Selenium, Cypress, or equivalent), including API testing with tools such as Postman or REST Assured.
• Hands-on experience testing custom cloud services including REST/GraphQL APIs, Azure Functions, Logic Apps, and event-driven architectures (Azure Service Bus, Event Hub).
• Familiarity with performance and load testing tools such as Azure Load Testing for cloud services and web applications.
• Familiarity with networking and security concepts relevant to edge computing (TCP/IP, MQTT, TLS/SSL, VPN).
• Strong analytical and problem-solving skills with a systematic approach to debugging, defect isolation, and risk-based testing.
• Applicants must be authorized to work in the United States without the need for current or future sponsorship

Preferred Qualifications:

• Microsoft Azure certifications (e.g., AZ-900, AZ-204, AZ-400, or IoT-specific certifications).
• Experience with SaMD (Software as a Medical Device) classification and the FDA's Digital Health Center of Excellence guidance.
• Knowledge of HIPAA and HL7/FHIR data standards for healthcare data handling and interoperability.
• Experience with medical device cybersecurity testing aligned to FDA Cybersecurity Guidance and NIST frameworks.
• Familiarity with observability tools such as Azure Monitor, Prometheus, or Grafana in a clinical data context.
• Experience with infrastructure-as-code tools such as Terraform or Bicep.
• Background in agile/scrum development methodologies adapted for regulated environments (e.g., SAFe for medical devices).
• Familiarity with electronic Quality Management Systems (eQMS) such as Grand Avenue Software, Veeva, MasterControl, or Greenlight Guru.

Benefits: We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.