Medical Device Software QA Engineer

Ad Astra Diagnostics, Inc. (AAD) is looking for an experienced Software Quality Assurance Engineer to assist the company in developing a class-leading Point-of-Care diagnostic platform for the human market in a small and dynamic team.

You will be leading the efforts of testing a Medical Device Software, including data communication features to Healthcare Data Endpoints, such as Electronic Medical Records (EMR) and Laboratory Information Systems (LIMS), and are comfortable setting up the required Testing Fixtures to conduct the testing activities.

You will also assist with customer troubleshooting to close a feedback loop between development and user acceptance of the device. Additionally, you will assist with the setup and troubleshooting of instruments in use for research activities at AAD and at customer sites, helping to ensure that the coverage of the test activities match the spirit and the needs of the software system in the hands of customers. You will also be actively participating in initiatives ensuring that the Computer Software Systems at AAD meet regulatory requirements.

Responsibilities Include:

• Create end-to-end test plans and test scenarios.
• Execute test plans and ensure that all the requirements are met, and that the software works as expected. The software is tested in terms of functionality, performance, reliability, stability, and compatibility with other legacy- and / or external systems.
• Review functional and design specifications to ensure full understanding of individual deliverables.
• Identify test requirements from specifications, map test case requirements and design test coverage plan.
• Develop, document, and maintain functional test cases and other test artifacts like the test data, data validation, harness scripts and automated scripts.
• Execute and evaluate manual or automated test cases and report test results.
• Hold and facilitate test plan/case reviews with cross-functional team members.
• Identify any potential quality issues per defined process and escalate potential quality issues to management.
• Ensure that validated deliverables meet functional and design specifications and requirements.
• Isolate, replicate, and report defects and verify defect fixes.
• Prepare test reports and participate in assessing residual risk.
• Investigate Customer issues, collect and analyze logs, report findings and recommendations to Engineering.
• Participate in activities in Risk Management and Usability Engineering Process.
• Generate content and maintain records in a Quality Management System.

Requirements:

• B.S. in Software or Biomedical Engineering or related field.
• 4+ years of experience as a Software Quality Assurance Engineer, with experience in writing test plans/cases, with hands-on experience with both white box and black box testing.
• Experience with testing software in medical devices.
• Experience with automated testing tools and frameworks.
• Experience with testing medical device communication results to Laboratory Information Systems and/or Electronic Health Records Systems.
• Knowledge of communications protocols used in health data applications (e.g.: HL7, FHIR or related standards).
• Experience with Software Management Tools (Jira, Azure DevOps or VSTS).
• Experience with testing Azure Cloud Environments.
• Experience with using a programming or scripting language (e.g.: C# or Python) to leverage testing tasks.
• Experience with at least one Data analysis tool (e.g.: Excel or R).
• Willingness to work in a fast-paced, multidisciplinary environment.

Desirable:

• Experience with testing cloud-connected medical devices.
• Experience with aspects of Quality in Medical Devices (ISO 13485, ISO 14971, IEC 62304, and IEC 62366), and FDA’s 510(k) process.
• Experience with writing Automated Unit Tests in DevOps.
• Experience with the use of SQL or other database-querying languages.
• Experience with testing device-oriented services in Microsoft Azure (e.g.: Azure Functions, IoT Hub, etc.).
• Experience in IT support, with understanding of wired and wireless networking and network security.
• Knowledge of principles of Computer Software Validation for systems used in development and manufacturing of medical devices.
• Experience with testing Point-of-Care medical devices.
• Experience with testing and troubleshooting embedded and electromechanical devices and lab instrumentation.

About AAD
At AAD, we are committed to our team and customers. We believe in fostering a culture that promotes creativity, learning, and leadership. Through our efforts and values, AAD has be