Medical Device Software QA Engineer

1 month ago

Morrisville, United States Ad Astra Diagnostics Full time
Job DescriptionJob DescriptionAd 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 been able to cultivate new ideas and create new technologies to revolutionize the healthcare industry. 

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

  • Medical Device Software QA Engineer

    3 months ago

    Morrisville, United States Ad Astra Diagnostics Full time

    Job DescriptionJob DescriptionAd 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...

  • Senior Embedded Software Engineer

    2 months ago

    Morrisville, United States Device Solutions Inc Full time

     Senior Software Engineer (Embedded Linux-Focused) Location: Morrisville, North CarolinaPay: Based on ExperiencePosition Type: Full-Time Exempt, In-Person (Hybrid)About Device Solutions: Device Solutions is a full-service engineering firm specializing in the design and development of low-power, wireless IoT devices. Since opening our doors in 2003, we...

  • Quality Assurance Engineer for Medical Software

    3 days ago

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

    Job OverviewAd Astra Diagnostics, Inc. (AAD) is seeking a skilled Software Quality Assurance Engineer to contribute to the development of an innovative Point-of-Care diagnostic platform tailored for the healthcare sector. You will be part of a small, agile team focused on delivering excellence.Key ResponsibilitiesLead the testing initiatives for Medical...

  • Quality Assurance Engineer for Medical Software

    1 week ago

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

    Job OverviewAd 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 aimed at the human market. This role is essential within our agile and innovative team.Your primary responsibility will be to oversee the testing of Medical Device Software,...

  • Quality Assurance Engineer for Medical Software

    3 days ago

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

    Job OverviewAd 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 aimed at the human market. You will be part of a small, agile team dedicated to excellence.Key ResponsibilitiesLead the testing efforts for Medical Device Software, focusing on...

  • Quality Assurance Engineer for Medical Software

    3 days ago

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

    Job OverviewAd 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 ResponsibilitiesLead the testing initiatives for Medical Device Software, focusing on data communication...

  • Quality Assurance Engineer for Medical Software

    1 week ago

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

    Job OverviewAd Astra Diagnostics, Inc. (AAD) is seeking a skilled Software Quality Assurance Engineer to contribute to the development of an innovative Point-of-Care diagnostic platform aimed at the human market within a collaborative and agile team environment.You will take the lead in testing Medical Device Software, focusing on data communication...

  • Quality Assurance Engineer for Medical Software

    4 days ago

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

    Job OverviewAd 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...

  • C# .NET Sr. Software Engineer

    1 week ago

    Morrisville, United States Ascom Full time

    Ascom has an opening on our team for a Sr. Software Engineer who is experienced in C# language and.NET. This position is with our Morrisville, NC office so you must reside in the USA and in the general area to Raleigh. Remote work is available; however, you may be required to be in the office on occasion. Sponsorship is not available. Ascomleads the way in...

  • GenAI Software Engineer

    14 hours ago

    Morrisville, North Carolina, United States Lenovo Full time

    About the RoleWe are seeking a highly skilled GenAI Engineer to join our team at Lenovo. As a key member of our cloud software division, you will play a crucial role in developing, deploying, and optimizing GenAI solutions for our core platform.Key ResponsibilitiesDesign and develop microservices architecture to power GenAI applicationsDeploy and manage...

  • Program Coordinator

    1 week ago

    Morrisville, North Carolina, United States Device Solutions Inc Full time

    Program CoordinatorLocation: Morrisville, North CarolinaCompensation: Based on ExperienceEmployment Type: Full-Time Exempt, In-Person (Hybrid)About Device Solutions Inc: Device Solutions Inc is a comprehensive engineering firm focused on the design and development of low-power, wireless IoT devices. Since our inception in 2003, we have positioned ourselves...

  • Device Support Analyst

    2 weeks ago

    Morrisville, United States Duke Health Full time

    At Duke Health, we're driven by a commitment to compassionate care that changes the lives of patients, their loved ones, and the greater community. No matter where your talents lie, join us and discover how we can advance health together.About Duke Health Technology SolutionsPursue your passion for caring and innovation with Duke Heath Technology...

  • Software Engineer in Test

    4 weeks ago

    Morrisville, United States ACT Professional Solutions Full time

    Morrisville, NC100% onsite required -4 days per week in office a mustAssignment until the end of the year with a possible extension until Feb 2025.We are seeking a strong and versatile software engineer who is driven to design, develop, and support ourtest automation efforts. Our electronics test team is focused on developing tools and applications used...

  • Backend Software Engineer

    4 weeks ago

    Morrisville, United States InsightFinder Inc. Full time

    InsightFinder provides innovative machine learning technology to unlock the value in IT operational data, from performance metrics to textual log files, finding root causes for deviations from normal behaviors and recurring patterns, as well as predicting future events and outages to reduce unnecessary human intervention. InsightFinder’s core technologies...

  • Quality Assurance Software Engineer

    1 week ago

    Morrisville, North Carolina, United States ACT Professional Solutions Full time

    Location: Morrisville, NCWork Arrangement: 100% onsite required - 4 days per week in office a mustContract Duration: Assignment until the end of the year with a possible extension.We are looking for a talented and adaptable Software Engineer in Test who is passionate about designing, developing, and enhancing our test automation initiatives. Our electronics...

  • Quality Assurance Software Engineer

    1 week ago

    Morrisville, North Carolina, United States ACT Professional Solutions Full time

    Location: Morrisville, NCWork Arrangement: 100% onsite required - 4 days per week in office is essential.Contract Duration: Assignment until the end of the year with a potential extension.We are in search of a highly skilled and adaptable software engineer dedicated to designing, developing, and enhancing our test automation initiatives. Our electronics...

  • Senior Software Engineer

    2 weeks ago

    Morrisville, United States Mainz Brady Group Full time

    I am seeking a Senior Software Engineer with a strong background in full-stack development, focusing on React for front-end and Python for back-end. In this role, you'll develop and maintain web applications, collaborate on projects, and ensure the delivery of high-quality products. A Bachelor’s Degree in Computer Science is required, along with 5+ years...

  • Senior Software Engineer

    2 weeks ago

    Morrisville, United States Mainz Brady Group Full time

    I am seeking a Senior Software Engineer with a strong background in full-stack development, focusing on React for front-end and Python for back-end. In this role, you'll develop and maintain web applications, collaborate on projects, and ensure the delivery of high-quality products. A Bachelor’s Degree in Computer Science is required, along with 5+ years...

  • Medical Device Assembly Technician

    20 hours ago

    Morrisville, North Carolina, United States Advantage Technical Full time

    Job DescriptionPrimary Responsibilities:Assemble, clean, and package Single-Use assemblies according to Engineering Process Records (EPR), drawings, and Standard Operating Procedures (SOP).Utilize appropriate personal protective equipment (PPEs) and report all near-miss incidents and first aid events.Adhere to cleanroom protocols and current Good...

  • Senior Embedded Software Engineer

    1 week ago

    Morrisville, North Carolina, United States Diverse Lynx Full time

    Senior Embedded Software Engineer Location: Onsite Role Contract Duration: 6-12 Months, subject to renewal based on performance Ideal Candidate Profile: We are seeking experienced software engineers with 3 to 5 years of expertise in developing, debugging, and testing embedded firmware. Responsibilities include managing firmware build tools,...