Software Engineer in Test

VivoSense, Inc. is hiring a Software Engineer in Test to ensure its software products are reliable, traceable, and appropriately verified and validated. The role develops testing strategies and automated and manual tests, maintains validation evidence, investigates defects, and supports quality-controlled software releases in a regulated environment.

Responsibilities:

• Develop and maintain software test strategies, test plans, test cases, test procedures, and validation documentation for new features and software releases
• Design, implement, and maintain automated test suites covering application workflows, APIs, integrations, regression testing, and other critical system functionality
• Integrate automated testing into CI/CD pipelines and build-triggered quality processes
• Perform risk-based testing, focusing verification effort on functionality that presents the greatest product, data integrity, security, or clinical risk
• Review product requirements, user stories, acceptance criteria, and technical designs to ensure they are clear, testable, and appropriately covered by verification activities
• Maintain traceability between requirements, risks, test cases, test execution, defects, and release evidence where required by the software lifecycle
• Execute formal and exploratory testing and accurately document test results and objective evidence
• Identify, document, investigate, and reproduce software defects and collaborate with developers to determine root cause and verify corrective actions
• Collaborate with Software Engineering, Science, Product Management, DevOps, and Quality to ensure releases successfully complete defined quality and validation gates
• Own software verification activities and ensure verification is appropriately planned, executed, documented, traceable, and completed in accordance with applicable quality procedures
• Support software validation activities for controlled releases and significant software changes, including validation planning, execution, documentation, and required evidence
• Ensure testing activities and documentation comply with VivoSense‘s Quality Management System, software development procedures, change-control processes, and applicable regulatory expectations
• Support investigations, nonconformances, corrective actions, or CAPA activities related to software quality when applicable
• Contribute to internal and external audit readiness by ensuring software quality records are accurate, complete, traceable, and reproducible
• Advocate for quality throughout the software development lifecycle rather than treating testing as a final release activity

Requirements:

• Bachelor's degree in computer science, Engineering, Information Technology, Science, or a related discipline, or equivalent practical experience
• 3–8 years of software testing, software quality engineering, or software validation experience
• Experience working in a regulated industry such as pharmaceuticals, biotechnology, clinical research, digital health, healthcare, or medical devices
• Practical understanding of software quality and validation principles within a controlled Quality Management System
• Experience developing and executing documented software test cases, test procedures, and test protocols
• Experience maintaining requirements-to-test traceability and documented verification/validation evidence
• Experience with software defect management, investigation, root-cause analysis, and regression testing
• Experience developing and maintaining automated software tests
• Understanding Agile software development and how Agile practices can operate within a regulated software lifecycle
• Experience collaborating with distributed software engineering, science/clinical, DevOps, and quality teams
• Strong documentation skills and attention to detail
• Ability to work independently, identify gaps, propose solutions, and take ownership of software quality activities
• Working knowledge of Git or another modern version-control system
• If you cannot work in the United States without sponsorship or extensions, we will not be able to accept your candidacy for this role
• Experience with regulated software frameworks or regulations such as 21 CFR Part 11, GxP, ISO 13485, IEC 62304, FDA software quality expectations, or comparable regulated software environments
• Experience with Computer Software Assurance (CSA), Computer System Validation (CSV), or risk-based software validation approaches
• Experience supporting software used in clinical trials or clinical research
• Experience testing cloud-native SaaS applications
• Experience testing REST APIs using tools such as Postman or automated API-testing frameworks
• Experience with AWS or other cloud platforms
• Experience in integrating automated tests into CI/CD pipelines
• Experience testing data-processing systems, analytics platforms, or applications that process scientific, physiological, or clinical data
• Experience with security, data integrity, audit trails, access control, or other regulated-system controls
• Experience helping establish or improve test automation frameworks and software quality processes within a growing organization