VivoSense, Inc. - Software Engineer in Test
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. • 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.
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.
Benefits
• Board approved stock options • Board approved annual bonus • Direct access to senior leadership • Professional growth training • 401K with Safe Harbor employer contribution • Flexible working hours • Base Salary Range: $120,000 - $140,000 (Depending on experience and location)
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