Medical Device Software QA Engineer

Ad Astra Diagnostics - Morrisville, NC

Full-time - Mid Level

Morrisville, NC

About the position

Ad Astra Diagnostics, Inc. (AAD) is seeking an experienced Software Quality Assurance Engineer to lead testing efforts for a Point-of-Care diagnostic platform. This role involves ensuring the quality of Medical Device Software, including data communication features to Healthcare Data Endpoints, and assisting with customer troubleshooting to enhance user acceptance. The engineer will also participate in regulatory compliance initiatives and support research activities.

Responsibilities

• Create end-to-end test plans and test scenarios.
• Execute test plans and ensure that all requirements are met, verifying software functionality, performance, reliability, stability, and compatibility.
• Review functional and design specifications to ensure understanding of deliverables.
• Identify test requirements from specifications and design a test coverage plan.
• Develop, document, and maintain functional test cases and other test artifacts.
• Execute and evaluate manual or automated test cases and report results.
• Facilitate test plan/case reviews with cross-functional team members.
• Identify and escalate potential quality issues to management.
• Ensure validated deliverables meet specifications and requirements.
• Isolate, replicate, and report defects and verify fixes.
• Prepare test reports and assess residual risk.
• Investigate customer issues, analyze logs, and report findings to Engineering.
• Participate in Risk Management and Usability Engineering Process activities.
• 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.
• 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).
• Experience with Software Management Tools (Jira, Azure DevOps or VSTS).
• Experience with testing Azure Cloud Environments.
• Experience with a programming or scripting language (e.g.: C# or Python).
• Experience with at least one Data analysis tool (e.g.: Excel or R).
• Willingness to work in a fast-paced, multidisciplinary environment.

Nice-to-haves

• Experience with testing cloud-connected medical devices.
• Experience with Quality in Medical Devices (ISO 13485, ISO 14971, IEC 62304, IEC 62366), and FDA's 510(k) process.
• Experience with writing Automated Unit Tests in DevOps.
• Experience with SQL or other database-querying languages.
• Experience with testing device-oriented services in Microsoft Azure.
• Experience in IT support, with understanding of wired and wireless networking and network security.
• Knowledge of Computer Software Validation principles for medical devices.
• Experience with testing Point-of-Care medical devices.
• Experience with testing and troubleshooting embedded and electromechanical devices.

Benefits

• Health insurance
• Dental insurance
• Vision insurance
• 401k
• Paid vacation