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Quality Assurance Engineer for Medical Software

2 months ago

Morrisville, North Carolina, United States Ad Astra Diagnostics Full time
Job Overview

Ad Astra Diagnostics, Inc. (AAD) is seeking a skilled Software Quality Assurance Engineer to play a pivotal role in the development of an advanced Point-of-Care diagnostic platform tailored for the healthcare sector within a small, agile team.

You will spearhead the testing initiatives for Medical Device Software, focusing on data communication functionalities with Healthcare Data Endpoints, including Electronic Medical Records (EMR) and Laboratory Information Systems (LIMS). Your expertise in establishing the necessary Testing Fixtures will be crucial for executing testing activities effectively.

Your role will also involve assisting customers with troubleshooting, thereby creating a feedback loop between development and user acceptance of the device. Furthermore, you will support the setup and troubleshooting of instruments utilized in research activities at AAD and at client locations, ensuring that testing coverage aligns with the operational needs of the software in customer environments. You will actively contribute to initiatives that ensure compliance of Computer Software Systems at AAD with regulatory standards.

Key Responsibilities:
  • Develop comprehensive end-to-end test plans and scenarios.
  • Implement test plans to verify that all requirements are fulfilled and that the software performs as intended, assessing functionality, performance, reliability, stability, and compatibility with other systems.
  • Analyze functional and design specifications to gain a thorough understanding of deliverables.
  • Determine test requirements from specifications, mapping them to test case requirements and designing a test coverage strategy.
  • Create, document, and maintain functional test cases and other testing artifacts, including test data, data validation, harness scripts, and automated scripts.
  • Conduct and assess manual or automated test cases, documenting test outcomes.
  • Facilitate test plan and case reviews with cross-functional team members.
  • Identify potential quality issues according to established processes and escalate them to management.
  • Ensure that validated deliverables meet the specified functional and design requirements.
  • Isolate, replicate, and report defects while verifying fixes.
  • Compile test reports and engage in evaluating residual risks.
  • Investigate customer issues, gather and analyze logs, and communicate findings and recommendations to the Engineering team.
  • Participate in Risk Management and Usability Engineering activities.
  • Generate content and maintain documentation within a Quality Management System.
Qualifications:
  • Bachelor's degree in Software or Biomedical Engineering or a related discipline.
  • A minimum of 4 years of experience as a Software Quality Assurance Engineer, including proficiency in writing test plans and cases, with practical experience in both white box and black box testing.
  • Experience in testing software for medical devices.
  • Familiarity with automated testing tools and frameworks.
  • Experience in validating medical device communication with Laboratory Information Systems and/or Electronic Health Records Systems.
  • Knowledge of communication protocols relevant to health data applications (e.g., HL7, FHIR, or similar standards).
  • Proficiency with Software Management Tools (e.g., Jira, Azure DevOps).
  • Experience in testing within Azure Cloud Environments.
  • Ability to utilize a programming or scripting language (e.g., C# or Python) to enhance testing processes.
  • Experience with at least one data analysis tool (e.g., Excel or R).
  • A willingness to thrive in a fast-paced, multidisciplinary environment.
Preferred Qualifications:
  • Experience in testing cloud-connected medical devices.
  • Familiarity with Quality standards in Medical Devices (ISO 13485, ISO 14971, IEC 62304, IEC 62366) and the FDA's 510(k) process.
  • Experience in writing Automated Unit Tests in a DevOps context.
  • Knowledge of SQL or other database-querying languages.
  • Experience in testing device-oriented services within Microsoft Azure (e.g., Azure Functions, IoT Hub).
  • Background in IT support, with an understanding of wired and wireless networking and network security.
  • Knowledge of Computer Software Validation principles for systems used in the development and manufacturing of medical devices.
  • Experience in testing Point-of-Care medical devices.
  • Experience in testing and troubleshooting embedded and electromechanical devices and laboratory instrumentation.

About AAD
At AAD, we prioritize our team and our customers. We are dedicated to fostering a culture that encourages creativity, learning, and leadership. Through our values and efforts, AAD has been able to cultivate innovative ideas and develop new technologies that aim to transform the healthcare industry.

We welcome passionate and driven professionals who are eager to make a positive impact on healthcare by providing relevant, valuable, and actionable information. We are committed to creating a diverse and inclusive environment that supports innovation and harnesses the talents of our workforce. We seek individuals who bring diverse perspectives, demonstrate integrity, and show commitment to our customers' success. We offer competitive benefits, including health, dental, and vision insurance, 401k, and paid vacation.