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Bengaluru, Karnataka, India
Hybrid
Available
Roles and Responsibilities
Own and lead verification activities for software and integrated medical device systems, ensuring compliance with product requirements, quality standards, and regulatory expectations.
Plan, develop, execute, and review verification protocols, test cases, and test reports for software, system, and hardware-software integrated solutions.
Ensure complete traceability between requirements, risks, design outputs, verification activities, and defects throughout the product lifecycle.
Drive risk-based verification strategies aligned with ISO 14971 and product risk management processes.
Collaborate with Systems, Software, Quality, Regulatory, Clinical, and Product teams to ensure comprehensive verification coverage.
Design, develop, and maintain scalable test automation frameworks for functional, integration, regression, performance, and system-level testing.
Develop automated test solutions for medical device software, cloud applications, connectivity solutions, and distributed systems.
Enhance test infrastructure, simulation environments, and continuous integration/continuous testing pipelines to improve product quality and release efficiency.
Create tools and utilities to improve test effectiveness, coverage analysis, defect detection, and traceability.
Ensure verification activities comply with applicable regulations and standards, including IEC 62304, ISO 13485, FDA Quality System Regulation (QSR), EU MDR, and cybersecurity requirements where applicable.
Support software release readiness activities by providing objective evidence of product quality and regulatory compliance.
Participate in design reviews, risk assessments, hazard analyses, and defect investigations.
Contribute to CAPA, audit responses, root cause investigations, and continuous quality improvement initiatives.
Define and promote verification best practices, testing methodologies, coding standards, and automation strategies across teams.
Mentor and coach junior verification engineers on test design, automation, regulatory compliance, and quality engineering practices.
Work closely with development teams to improve software testability, reliability, maintainability, and observability.
Lead defect triage activities, identify root causes, and ensure timely resolution of product quality issues.
Author, review, and maintain verification documentation including test plans, protocols, reports, traceability matrices, and compliance records.
Provide clear status reporting and quality metrics to project stakeholders.
Support internal, customer, and regulatory audits by presenting verification evidence and quality documentation.
Bachelor's or Master's Degree in Computer Science, Software Engineering, Electrical Engineering, Biomedical Engineering, or other STEM disciplines.
Advanced experience in software verification, quality engineering, or validation of regulated products, preferably in the medical device domain.
Extensive experience in software verification and test automation for complex software and medical device systems.
Strong programming skills in Playwright and Type script, Python, or similar languages with emphasis on test automation and white-box and black box testing techniques.
Experience developing and executing automated functional, integration, system, API, and regression tests.
Experience testing web services, REST APIs, cloud-native applications, and distributed systems.
Hands-on experience with CI/CD tools such as Jenkins, Azure DevOps, GitHub Actions, or equivalent.
Experience with test management, defect tracking, and requirements management tools.
Strong understanding of Linux/Unix and Windows environments.
Experience with virtualization, containers, simulated environments, hardware-in-the-loop (HIL), and device integration testing.
Strong knowledge of test automation techniques including data-driven testing, pairwise testing, mocking, stubbing, fault injection, and test hooks.
Experience working within regulated environments following IEC 62304, ISO 13485, FDA, EU MDR, and related standards.
Understanding of software verification and validation processes throughout the medical device lifecycle.
Experience with requirements traceability, risk controls verification, cybersecurity testing, and software safety classifications.
Familiarity with Design Controls, DHF, DMR, CAPA, Change Control, and Risk Management processes.
Experience supporting regulatory submissions and audit readiness activities is highly desirable.
Strong analytical and problem-solving capabilities with the ability to evaluate complex technical and quality challenges.
Experience verifying scalable, reliable, and highly available healthcare systems and medical device software solutions.
Ability to decompose complex verification activities into well-defined tasks and provide realistic effort estimates.
Demonstrates customer-focused thinking by understanding how product quality, safety, reliability, and regulatory compliance impact patient outcomes and clinical workflows.
Champions a culture of quality, patient safety, continuous improvement, and engineering excellence across the organization
Inclusion and Diversity
GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, colour, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
We expect all employees to live and breathe our behaviours: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you would expect from an organization with global strength and scale, and you will be surrounded by career opportunities in a culture that fosters care, collaboration and support.
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Relocation Assistance Provided: Yes
