Senior Software Test Engineer

Abbott; California (MO); On-site; USD 90,000 - 180,000; Full time

Job summary

Abbott is seeking a Software Test Engineer based in California. This role involves leading software verification and validation for cloud and mobile platforms within a regulated medical device environment. The successful candidate will execute end-to-end verification, develop test plans, and ensure compliance with FDA and ISO standards. A Bachelor’s degree and significant experience in software verification and automation are required. The position offers a competitive salary range between $90,000 and $180,000.

Qualifications

• 6+ years of experience in software verification and quality engineering.
• 2+ years of experience in medical device software development under FDA regulations.
• Strong expertise in V&V, including defect management and requirements traceability.

Responsibilities

• Execute end‑to‑end software verification for cloud services and mobile applications.
• Develop and improve verification plans in compliance with regulatory standards.
• Mentor and guide junior test engineers on best practices.

Skills

Software verification

Test automation

Regulatory compliance

Analytical skills

Communication skills

Education

Bachelor's degree in software engineering or related field

Tools

GitHub Actions

Azure Pipelines

Python

JavaScript

TypeScript

Job description

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.