Staff Software Test Engineer - Medical Device Automation

Abbott; Alameda (CA); On-site; USD 114,000 - 228,000; Full time

Job summary

Abbott in Alameda, CA is seeking a Staff Software Test Engineer to lead verification and validation across cloud and mobile platforms within a regulated medical device environment.

You will own end-to-end software verification for cloud services, mobile apps, and connected devices, translating requirements into test strategies, plans, and execution steps while collaborating with product, engineering, and QA teams to ensure regulatory compliance and quality.

Qualifications

• Bachelor's degree in software engineering or related field.
• 10+ years of experience in software verification and quality engineering.
• 3+ years of experience in medical device software development under FDA 21 CFR 820, ISO 13485, and IEC 62304.
• Strong expertise in medical device V&V, including defect management and requirements traceability.

Responsibilities

• Own and execute end-to-end software verification for cloud services, mobile applications, and connected devices, ensuring quality throughout the development lifecycle.
• Translate product and technical requirements into verification strategies, test plans, test cases, and execution plans.
• Develop, maintain, and improve verification plans, protocols, and reports in compliance with FDA 21 CFR, ISO 13485, IEC 62304.

Skills

Software verification

Quality engineering

Test automation

CI/CD

Python/JS/TS

Education

Bachelor's degree in software engineering or related field

Tools

GitHub Actions

Azure Pipelines

Harness

Job description

Abbott in Alameda, CA is seeking a Staff Software Test Engineer to lead verification and validation across cloud and mobile platforms within a regulated medical device environment.

You will own end-to-end software verification for cloud services, mobile apps, and connected devices, translating requirements into test strategies, plans, and execution steps while collaborating with product, engineering, and QA teams to ensure regulatory compliance and quality.