Senior Software Test Engineer - Medical Device QA Lead

Abbott Laboratories; Alameda (CA); On-site; USD 90,000 - 180,000; Full time

Benefits offered by this job

Health coverage

Retirement plan

Tuition reimbursement

Free education benefits

Job summary

Abbott Laboratories in Alameda, CA is seeking a Senior Software Test Engineer to lead verification across cloud, mobile, and connected devices within a regulated medical device environment.

You will own end-to-end software verification, develop test plans, and drive automation in CI/CD pipelines while ensuring regulatory compliance under FDA 21 CFR, ISO 13485, and IEC 62304. Collaboration with product and engineering teams is essential.

Qualifications

• Bachelor’s degree in software engineering or related field or equivalent experience.
• 6+ years in software verification and quality engineering.
• 2+ years in medical device software development under FDA 21 CFR 820, ISO 13485, and IEC 62304.
• Experience with test automation across mobile, web, API, or similar platforms.
• Experience with modern CI/CD ecosystems like GitHub Actions, Azure Pipelines, Harness.
• Excellent analytical, communication, and documentation skills.

Responsibilities

• Own end-to-end software verification for cloud services, mobile apps, and devices.
• Translate requirements into verification strategies, plans, and test cases.
• Develop, maintain, and improve verification plans, reports, and regulatory alignment.
• Partner with product managers, architects, developers, and quality teams.
• Support risk management activities, including analysis and root-cause investigations.
• Design scalable manual and automated testing spanning functional to regression testing.

Skills

Software verification

Quality engineering

Test automation

CI/CD

Regulatory compliance

Education

Bachelor’s degree in software engineering or related field

Tools

GitHub Actions

Azure Pipelines

Playwright

REST Assured

Job description

Abbott Laboratories in Alameda, CA is seeking a Senior Software Test Engineer to lead verification across cloud, mobile, and connected devices within a regulated medical device environment.

You will own end-to-end software verification, develop test plans, and drive automation in CI/CD pipelines while ensuring regulatory compliance under FDA 21 CFR, ISO 13485, and IEC 62304. Collaboration with product and engineering teams is essential.