This is a Fully Remote Job
About Our Client:
VivoSense operates in the digital health technology sector, specializing in wearable sensors, mobile applications, and connected monitoring tools. The organization collaborates with pharmaceutical sponsors, healthcare providers, and academic groups to develop real-world digital clinical measures supported by scientific and analytic expertise.
About the Opportunity:
The SOFTWARE ENGINEER IN TEST role focuses on ensuring that software products are reliable, traceable, and properly verified and validated for their intended use within a regulated environment. This position significantly contributes to maintaining software quality by defining test strategies, developing automated and manual tests, and supporting software releases through quality gates.
Responsibilities:
Develop and maintain test strategies, plans, cases, procedures, and validation documentation for software features and releases.
Design and maintain automated test suites covering workflows, APIs, integrations, and regression testing.
Integrate automated tests into CI/CD pipelines and quality processes.
Perform risk-based testing to focus on critical product, data integrity, security, or clinical risks.
Review and ensure clarity and testability of product requirements, user stories, and designs.
Maintain traceability among requirements, risks, test cases, execution, defects, and release evidence.
Execute formal and exploratory testing with accurate documentation of results.
Identify, document, and investigate software defects; collaborate with developers on root cause and fixes.
Collaborate across teams to ensure releases meet quality and validation criteria.
Own software verification activities in compliance with quality procedures.
Support validation activities for controlled releases and significant changes.
Ensure testing complies with quality management systems, development procedures, and regulatory expectations.
Participate in investigations, corrective actions, and audit readiness related to software quality.
Advocate for quality throughout the software development lifecycle.
Requirements:
Bachelor’s degree in computer science, engineering, IT, science, or related field, or equivalent experience.
3–8 years in software testing, quality engineering, or software validation.
Experience in regulated industries such as pharmaceuticals, biotechnology, digital health, healthcare, or medical devices.
Knowledge of software quality and validation principles within controlled Quality Management Systems.
Experience developing and executing documented test cases and validation evidence.
Ability to maintain requirements-to-test traceability.
Experience with defect management, root cause analysis, and regression testing.
Experience in developing and maintaining automated tests.
Understanding of Agile software development within regulated environments.
Experience collaborating with distributed teams in software engineering, science, DevOps, and quality.
Strong documentation skills and attention to detail.
Ability to work independently and take ownership of software quality activities.
Working knowledge of Git or similar version control systems.
Pay Range and Compensation Package:
The pay range and compensation package for this role will be determined based on the candidate's experience, skills, and other relevant factors.
Equal Opportunity Statement:
Our client is an equal opportunity employer. They celebrate diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, or national origin.
Note:
TalentHop is a recruitment partner of this role. Please note that all employment decisions, including candidate assessment, interviews, hiring, compensation, and employment terms, are made exclusively by the hiring employer.