12 days ago
Base Salary
$90k - $180k/yr
Responsibilities
- Own and execute end-to-end software verification for cloud services, mobile applications, and connected devices.
- Translate product and technical requirements into verification strategies, test plans, test cases, and execution plans.
- Create and maintain verification plans, protocols, and reports in compliance with FDA 21 CFR, ISO 13485, IEC 62304, and related standards.
- Partner with product managers, architects, developers, and quality teams to ensure requirements are testable, traceable, and aligned with verification strategies.
- Support risk analysis, defect triage, impact assessments, root-cause investigations, design reviews, and verification of design inputs and outputs.
- Design and implement scalable manual and automated functional, integration, system, and regression testing.
- Evolve test automation frameworks and CI/CD pipelines and drive improvements in verification processes, metrics, and automation coverage.
- Mentor junior test engineers and promote engineering discipline, automation best practices, and regulatory excellence.
Requirements
- Bachelor’s degree in software engineering or a related field, or equivalent practical experience.
- At least 6 years of experience in software verification and quality engineering.
- At least 2 years of experience with medical device software development under FDA 21 CFR 820, ISO 13485, and IEC 62304.
- Strong expertise in medical device verification and validation, defect management, and requirements traceability.
- Experience identifying and implementing test automation across mobile, web, API, or similar platforms.
- Experience with modern CI/CD ecosystems such as GitHub Actions, Azure Pipelines, or Harness.
- Preferred experience includes regulated healthcare or consumer health environments, scalable automation frameworks, Python, JavaScript, TypeScript, system integration, end-to-end software and hardware testing, and cloud-native architecture testing.
- Preferred qualifications include familiarity with CGM, biosensor, or IoT data integration; AI or data-driven consumer features; and high-growth technology or startup environments.
Benefits
- The position is onsite in Alameda, California.
- Benefits include potential free medical coverage through the Health Investment Plan PPO, an employer-contributed retirement savings plan, tuition reimbursement, the Freedom 2 Save student debt program, and the FreeU education benefit.
- The role offers career development with an international company and access to health and wellness benefits.
Tech Stack
Categories
About Abbott
Abbott is a NYSE‑listed healthcare company that develops diagnostics, medical devices, nutrition products, and branded generic medicines for clinicians and consumers. Founded in 1888 and headquartered in Abbott Park, Illinois, it sells products in more than 160 countries, including the FreeStyle Libre continuous glucose monitoring system. Revenue comes primarily from product sales to hospitals, clinics, and retail channels.