Ad Astra Diagnostics is Hiring a Medical Device Software QA Engineer Near Morrisville, NC
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 AADAt We welcome enthusiastic, driven professionals, passionate about positively impacting healthcare by providing relevant, valuable, and actionable information. We are devoted to creating a diverse and inclusive environment in order to best support innovation and the talents of our people. We look for people who bring diverse ideas, demonstrate integrity and show dedication to the success of our customers. We offer competitive benefits, including health, dental, and vision insurance, 401k, and paid vacation. Powered by JazzHR yyaAm0VwzS