Senior Software Test Engineer

About the Role

We are seeking a Software Test Engineer to lead verification and validation efforts across our cloud and mobile platforms within a regulated medical device environment. This role is based in Alameda, CA, and plays a critical role in ensuring product quality, regulatory compliance, and scalable delivery.

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 comprehensive verification strategies, test plans, test cases, and execution plans.
• Develop, maintain, and continuously improve verification plans, protocols, and reports in compliance with FDA 21 CFR, ISO 13485, IEC 62304, and related standards.
• Partner closely with product managers, architects, developers, and quality teams to ensure requirements are testable, traceable, and aligned with verification strategies.
• Support risk management activities, including risk analysis, defect triage, impact assessments, and root‑cause investigations.
• Participate in design reviews and verify design inputs and outputs meet regulatory and quality expectations.
• Design and implement scalable manual and automated testing strategies spanning functional, integration, system, and regression testing.
• Contribute to and evolve test automation frameworks and CI/CD pipelines, embedding quality into continuous delivery workflows.
• Drive continuous improvement across verification processes, tools, metrics, and automation coverage.
• Mentor and guide junior test engineers, promoting strong engineering discipline, automation best practices, and regulatory excellence.

Required Qualifications

• Bachelor’s degree in software engineering or a related field, or equivalent practical experience.
• 6+ years of experience in software verification and quality engineering.
• 2+ 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.
• Demonstrated experience identifying and implementing test automation opportunities across mobile, web, API, or similar platforms.
• Experience working within modern CI/CD ecosystems (e.g., GitHub Actions, Azure Pipelines, Harness).
• Excellent analytical, communication, and documentation skills, with a collaborative mindset.

Preferred Qualifications

• Background in healthcare or other regulated industries.
• Strong automation‑first mindset.
• Hands‑on experience building scalable automation frameworks (e.g., Pitesti, Playwright, Jest, REST Assured).
• Proficiency in Python, JavaScript, or TypeScript, with the ability to create reusable automation tools.
• Solid understanding of SDLC, QA methodologies, and compliance requirements such as HIPAA and GDPR.
• Experience with system integration and end‑to‑end testing involving both software and hardware components.
• Familiarity with cloud‑native architectures and microservices testing.

The base pay for this position is $90,000.00 – $180,000.00. In specific locations, the pay range may vary from the range posted.

Abbott is an Equal Opportunity Employer, committed to employee diversity.