Medical Device Software Quality Assurance Engineer

2 weeks ago

Morrisville, North Carolina, United States Ad Astra Diagnostics Full time
Job Title: Medical Device Software Quality Assurance Engineer

We are seeking an experienced Software Quality Assurance Engineer to join our team at Ad Astra Diagnostics, Inc. (AAD). As a key member of our small and dynamic team, you will play a crucial role in developing a class-leading Point-of-Care diagnostic platform for the human market.

Job Summary

The successful candidate will be responsible for leading the efforts of testing Medical Device Software, including data communication features to Healthcare Data Endpoints, such as Electronic Medical Records (EMR) and Laboratory Information Systems (LIMS). You will also assist with customer troubleshooting, setup, and troubleshooting of instruments in use for research activities at AAD and at customer sites.

Responsibilities
  • Create end-to-end test plans and test scenarios to ensure the software meets functional and design specifications.
  • Execute test plans and ensure that all requirements are met, and that the software works as expected.
  • 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 plans.
  • Develop, document, and maintain functional test cases and other test artifacts like 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.
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.

  • Hardware Engineering Team Lead

    2 weeks ago

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

    Job Title: Hardware Engineering ManagerDevice Solutions Inc is seeking a highly skilled and experienced Hardware Engineering Manager to lead our hardware engineering team in designing cutting-edge solutions that exceed customer expectations.Key Responsibilities:Provide technical oversight to the hardware engineering team to ensure projects are executed...

  • Medical Device Assembler

    3 weeks ago

    Morrisville, North Carolina, United States Advantage Technical Full time

    Medical Device Assembler Job DescriptionWe are seeking a skilled Medical Device Assembler to join our team at Advantage Technical. As a Medical Device Assembler, you will be responsible for assembling, cleaning, and packaging Single-Use assemblies according to Engineering Process Records (EPR), drawings, and Standard Operating Procedures (SOP).Key...

  • Software Engineer

    5 days ago

    Morrisville, North Carolina, United States Bertelsmann Full time

    Software Engineer (Front-end)Relias is seeking a highly skilled Software Engineer (Front-end) to join our team. As a key member of our Scrum team, you will be responsible for developing and delivering high-quality front-end solutions using Vue, TypeScript, and modern front-end technologies like CSS, SASS/LESS, and HTML.Key Responsibilities:Collaborate with...

  • Quality Assurance Specialist

    4 weeks ago

    Morrisville, North Carolina, United States LSG Sky Chefs Full time

    LSG Sky Chefs is a leading airline catering and hospitality provider, renowned for its exceptional quality and innovative approach. As a Quality Assurance Coordinator, you will play a vital role in maintaining our Global Quality System, ensuring compliance with customer, FDA, USDA, and HACCP plans. Your primary responsibility will be to monitor and maintain...

  • Quality Assurance Specialist

    4 weeks ago

    Morrisville, North Carolina, United States LSG Sky Chefs Full time

    About LSG Sky Chefs We are a leading airline catering and hospitality provider, renowned for our exceptional quality and innovative approach. Our team is dedicated to delivering outstanding culinary experiences and exceptional service to our clients and their passengers across North and Latin America. Job Summary We are seeking a Quality Assurance...

  • Quality Assurance Manager, GCP

    2 weeks ago

    Morrisville, North Carolina, United States WEP Clinical Full time

    Quality Assurance Manager, GCPAt WEP Clinical, we're committed to delivering high-quality services that meet the needs of our clients and patients. As a Quality Assurance Manager, GCP, you'll play a critical role in ensuring that our operations meet the highest standards of quality and compliance.Key Responsibilities:Develop and implement quality management...

  • Quality Assurance Specialist II

    3 weeks ago

    Morrisville, North Carolina, United States Encoded Therapeutics Full time

    Job Title: Specialist II, Quality AssuranceEncoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery.We are seeking a highly skilled Specialist II, Quality Assurance to provide quality oversight...

  • Quality Assurance Specialist

    4 weeks ago

    Morrisville, North Carolina, United States Chili's Grill & Bar Full time

    Quality Assurance SpecialistAt Chili's Grill & Bar, we're committed to delivering exceptional dining experiences to our guests. As a Quality Assurance Specialist, you'll play a vital role in ensuring that every dish that leaves our kitchen meets our high standards of quality and taste.Key Responsibilities:• Ensure that food is prepared to our company's...

  • Quality Assurance Specialist II

    3 weeks ago

    Morrisville, North Carolina, United States Encoded Therapeutics Full time

    Job Title: Specialist II, Quality AssuranceEncoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery.We are seeking a highly skilled Specialist II, Quality Assurance to provide quality oversight...

  • Embedded Software Test Engineer

    3 weeks ago

    Morrisville, North Carolina, United States Rogers Freels & Associates Inc Full time

    Job Title: Embedded Software Test EngineerWe are seeking a highly skilled Embedded Software Test Engineer to join our team at Rogers Freels & Associates Inc. As an Embedded Software Test Engineer, you will be responsible for testing and validating electrical systems and software that control vehicle operation and functions.Key Responsibilities:Create and...

  • Quality Assurance Coordinator

    4 weeks ago

    Morrisville, North Carolina, United States LSG Sky Chefs Full time

    About LSG Sky ChefsLSG Sky Chefs is a leading global provider of airline catering and hospitality services, renowned for its exceptional quality and innovative approach. As a trusted partner to the airline industry, we strive for excellence in every aspect of our operations.Job SummaryWe are seeking a highly skilled Quality Assurance Coordinator to join our...

  • Software Engineer

    7 days ago

    Morrisville, North Carolina, United States aKUBE Full time

    About the RoleWe are seeking a highly skilled Full Stack Engineer to join our team at aKUBE. As a key member of our Media Engineering organization, you will be responsible for designing and building scalable, efficient, and innovative solutions for our media processing pipelines.Key ResponsibilitiesCraft web application software using REACT, with strong...

  • Quality Assurance Specialist

    2 days ago

    Morrisville, North Carolina, United States Actalent Full time

    Job OverviewWe are seeking a highly motivated Quality Control Associate to join our team at a global CDMO in pharmaceutical manufacturing. This is an exciting opportunity to break into an Analytical Chemistry group with minimal experience.The successful candidate will be responsible for supporting facility testing at our new local facility, ensuring...

  • Medical Device Assembly Technician

    1 month 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 C++ Embedded Software Engineer

    1 month ago

    Morrisville, North Carolina, United States Diverse Lynx Full time

    Job DescriptionWe are seeking a highly skilled Senior C++ Embedded Software Engineer to join our team at Diverse Lynx LLC. As a key member of our engineering team, you will be responsible for designing, developing, and testing embedded firmware for our clients.Key ResponsibilitiesDesign and develop embedded firmware using C/C++ programming languagesManage...

  • Technical Software Program Manager

    3 days ago

    Morrisville, North Carolina, United States Adecco Full time

    Job SummaryWe are seeking a skilled Technical Software Program Manager to join our Android Software Platform team. As a key member of our team, you will be responsible for owning quarterly release content and individual software development projects. This includes end-to-end planning, tracking progress and risks, and reporting. You will ensure adherence to...

  • NextWave Sales Engineer

    2 weeks ago

    Morrisville, North Carolina, United States Lenovo Full time

    About LenovoLenovo is a global technology powerhouse, ranked #248 in the Fortune Global 500, and serving millions of customers every day in 180 markets. Focused on a bold vision to deliver Smarter Technology for All, Lenovo has built on its success as the world's largest PC company with a full-stack portfolio of AI-enabled, AI-ready, and AI-optimized devices...

  • Technical Software Program Manager

    2 weeks ago

    Morrisville, North Carolina, United States Adecco Full time

    Job DescriptionJob DescriptionTechnical Software Program ManagerAdecco is seeking a skilled Technical Software Program Manager to join our client's Android Software Platform team. As a key member of this team, you will be responsible for owning quarterly release content and individual software development projects. This includes end-to-end planning, tracking...

  • Senior Manager of Quality Operations

    3 weeks ago

    Morrisville, North Carolina, United States Jobot Full time

    {"title": "Senior Manager of Quality Operations", "company": "Jobot", "location": "Remote", "job_type": "Full-time", "salary": "$130,000 - $160,000 per year", "benefits": "Bonus + Equity + 401(k) + Health Benefits", "job_summary": "We are a rapidly growing therapeutics company with an approved drug on the market, leveraging scientific advances in B-cell...

  • Senior Manager of Quality Operations

    3 weeks ago

    Morrisville, North Carolina, United States Jobot Full time

    {"title": "Senior Manager of Quality Operations", "company": "Jobot", "location": "Remote", "job_type": "Full-time", "salary": "$130,000 - $160,000 per year", "benefits": "Bonus + Equity + 401(k) + Health Benefits", "job_description": "About the JobWe are a rapidly growing therapeutics company with an approved drug on the market, leveraging scientific...