Staff SW Test Engineer

Overview

Lead software verification and validation for cloud services, mobile applications and connected devices on Abbott's Lingo health platform, within a regulated medical device environment.

What you'll do

• Own and execute end-to-end software verification for cloud services, mobile applications, and connected devices across the development lifecycle.
• Translate product and technical requirements into 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 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.
• Drive continuous improvement across verification processes, tools, metrics, and automation coverage.
• Mentor and guide junior test engineers, promoting engineering discipline, automation best practices, and regulatory excellence.

What you'll need

• Bachelor's degree in software engineering or a related field, or equivalent practical experience.
• 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.
• Demonstrated experience identifying and implementing test automation opportunities across mobile, web, API, or similar platforms.
• Excellent analytical, communication, and documentation skills, with a collaborative mindset.
• Hands-on experience building scalable automation frameworks (e.g., PyTest, Playwright, Jest, REST Assured).
• Proficiency in Python, JavaScript, or TypeScript, with the ability to create reusable automation tools.

Nice to have

• Background in healthcare or other regulated industries.
• 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.

Details

• Location: Hyderabad, India (Abbott Healthcare Pvt Ltd).
• Work shift: Standard.
• Significant work activity: continuous standing for more than 2 consecutive hours in an 8-hour day.