Remote Regulated Software Validation Engineer

VivoSense, Inc.; Boston (MA); Remote; USD 120,000 - 140,000; Full time

Benefits offered by this job

Unlimited PTO

Stock options

Annual bonus

Remote work

Healthcare

Vision/Dental

401K

Professional growth

Job summary

VivoSense is seeking a Software Engineer in Test to help ensure our digital health software is reliable, traceable, and compliant with quality requirements. You will define test strategies, build automated tests, support validation activities, and contribute to release readiness.

You will collaborate with Software Engineering, Product Management, DevOps, and Quality to implement risk-based testing, maintain documentation, and improve testing frameworks within a growing organization.

Qualifications

• Bachelor's degree in computer science or related discipline.
• 3–8 years of software testing/quality engineering experience.
• Experience in regulated industries such as pharma/biotech/digital health.
• Knowledge of software quality and validation in a controlled QMS.
• Experience documenting verification/validation evidence.
• Experience developing and maintaining automated tests.

Responsibilities

• Develop test strategies, plans, and validation docs for new features.
• Design and maintain automated test suites for workflows, APIs, and regression testing.
• Integrate automated testing into CI/CD pipelines and release processes.
• Perform risk-based testing focusing on highest risk areas.
• Review requirements and designs to ensure clear, testable criteria.
• Maintain traceability between requirements, risks, tests, and releases.
• Execute formal and exploratory testing and document results with evidence.
• Identify and reproduce defects and work with developers on fixes.
• Collaborate with cross-functional teams to ensure successful releases.
• Own verification activities and ensure compliance with procedures.

Skills

Test strategies

Automation testing

CI/CD pipelines

Risk-based testing

Traceability

Documentation

Collaboration

Git

Regulated QA

Validation

Education

Bachelor's degree

Tools

Postman

AWS

Jenkins

Job description

VivoSense is seeking a Software Engineer in Test to help ensure our digital health software is reliable, traceable, and compliant with quality requirements. You will define test strategies, build automated tests, support validation activities, and contribute to release readiness.

You will collaborate with Software Engineering, Product Management, DevOps, and Quality to implement risk-based testing, maintain documentation, and improve testing frameworks within a growing organization.