Staff Automation & Verification Lead

Job description

Job Description Summary Responsible for test creation, testing a large module or a large component and designing a feature, set of features, or whole feature area independently, contributing to the immediate team and to other teams across business; Leading software quality engineering discussions and mentoring of other junior quality engineers. GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world. Job Description Roles and Responsibilities Verification&ValidationLeadership • 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. TestAutomation&Infrastructure • 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. Quality&Compliance • 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. TechnicalLeadership • 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. Documentation&Reporting • 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. EducationQualification • 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. DesiredCharacteristics/TechnicalExpertise TechnicalSkills • 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. MedicalDeviceDomainExpertise • 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. BusinessAcumen • 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