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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 contribute to the development of an advanced Point-of-Care diagnostic platform tailored for the healthcare sector within a small, agile team.

Key Responsibilities
  • Lead 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).
  • Set up and manage the necessary Testing Fixtures to facilitate comprehensive testing activities.
  • Support customer troubleshooting efforts to enhance the feedback loop between development and user acceptance.
  • Assist in the configuration and troubleshooting of instruments utilized for research at AAD and client locations, ensuring alignment of testing coverage with software system requirements.
  • Engage in initiatives to ensure that AAD's Computer Software Systems comply with regulatory standards.
Essential Duties
  • Develop 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 existing systems.
  • Review functional and design specifications to gain a comprehensive understanding of deliverables.
  • Identify testing requirements from specifications, mapping them to test cases and designing a coverage plan.
  • Create, document, and maintain functional test cases and associated artifacts, including test data and automated scripts.
  • Execute and assess both manual and automated test cases, documenting results.
  • Facilitate test plan and case reviews with cross-functional teams.
  • Detect potential quality issues and escalate them as per established processes.
  • Ensure that validated outputs meet functional and design specifications.
  • Isolate, replicate, and report defects while verifying fixes.
  • Compile test reports and participate in evaluating residual risks.
  • Investigate customer issues, analyze logs, and communicate findings to Engineering.
  • Contribute to Risk Management and Usability Engineering activities.
  • Generate content and maintain records 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, with a background in creating test plans and cases, along with practical experience in both white box and black box testing.
  • Proficiency in testing software for medical devices.
  • Experience with automated testing tools and frameworks.
  • Familiarity with testing medical device communications to Laboratory Information Systems and/or Electronic Health Records Systems.
  • Knowledge of communication protocols utilized in health data applications (e.g., HL7, FHIR).
  • Experience with Software Management Tools (e.g., Jira, Azure DevOps).
  • Experience in testing Azure Cloud Environments.
  • Ability to use a programming or scripting language (e.g., C# or Python) for testing tasks.
  • Experience with at least one data analysis tool (e.g., Excel or R).
  • Willingness to thrive in a fast-paced, multidisciplinary environment.
Preferred Qualifications
  • Experience with testing cloud-connected medical devices.
  • Knowledge of 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.
  • Familiarity with SQL or other database-querying languages.
  • Experience in testing device-oriented services in 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 in medical device development and manufacturing.
  • Experience with 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 customers, fostering a culture that encourages creativity, learning, and leadership. Our commitment to innovation has allowed us to develop groundbreaking technologies that aim to transform the healthcare landscape.

We value enthusiastic and driven professionals who are passionate about making a positive impact in healthcare by providing relevant and actionable information. We are dedicated to creating a diverse and inclusive environment that supports innovation and harnesses the talents of our team. We seek individuals who bring diverse perspectives, demonstrate integrity, and are committed to our customers' success. We offer competitive benefits, including health, dental, and vision insurance, 401k, and paid vacation.