09 Sep
|
GE Healthcare
|
Bengaluru
09 Sep
GE Healthcare
Bengaluru
**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** **&** **Validation** **Leadership** + Ownandleadverificationactivitiesforsoftwareandintegratedmedicaldevicesystems,ensuringcompliancewithproductrequirements,qualitystandards,andregulatoryexpectations. + Plan,develop,execute,andreviewverificationprotocols,testcases,andtestreportsforsoftware,system,andhardware-softwareintegratedsolutions. + Ensurecompletetraceabilitybetweenrequirements,risks,designoutputs,verificationactivities,anddefectsthroughouttheproductlifecycle. + Driverisk-basedverificationstrategiesalignedwithISO14971andproductriskmanagementprocesses. + CollaboratewithSystems,Software,Quality,Regulatory,Clinical,andProductteamstoensurecomprehensiveverificationcoverage. **Test** **Automation** **&** **Infrastructure** + Design,develop,andmaintainscalabletestautomationframeworksforfunctional,integration,regression,performance,andsystem-leveltesting. + Developautomatedtestsolutionsformedicaldevicesoftware,cloudapplications,connectivitysolutions,anddistributedsystems. + Enhancetestinfrastructure,simulationenvironments,andcontinuousintegration/continuoustestingpipelinestoimproveproductqualityandreleaseefficiency. + Createtoolsandutilitiestoimprovetesteffectiveness,coverageanalysis,defectdetection,andtraceability. **Quality** **&** **Compliance** + Ensure verificationactivitiescomplywithapplicableregulationsandstandards,includingIEC62304,ISO13485,FDAQualitySystemRegulation(QSR),EUMDR,andcybersecurityrequirementswhereapplicable. + Supportsoftwarereleasereadinessactivitiesbyprovidingobjectiveevidenceofproductqualityandregulatorycompliance. + Participateindesignreviews,riskassessments,hazardanalyses,anddefectinvestigations.
+ ContributetoCAPA,auditresponses,rootcauseinvestigations,andcontinuousqualityimprovementinitiatives. **Technical** **Leadership** + Defineandpromoteverificationbestpractices,testingmethodologies,codingstandards,andautomationstrategiesacrossteams. + Mentorandcoachjuniorverificationengineersontestdesign,automation,regulatorycompliance,andqualityengineeringpractices. + Workcloselywithdevelopmentteamstoimprovesoftwaretestability,reliability,maintainability,andobservability. + Leaddefecttriageactivities,identifyrootcauses,andensuretimelyresolutionofproductqualityissues. **Documentation** **&** **Reporting** + Author,review,andmaintainverificationdocumentationincludingtestplans,protocols,reports,traceabilitymatrices,andcompliancerecords. + Provideclearstatusreportingandqualitymetricstoprojectstakeholders. + Supportinternal,customer,andregulatoryauditsbypresentingverificationevidenceandqualitydocumentation. **Education** **Qualification** + Bachelor'sorMaster'sDegreeinComputerScience,SoftwareEngineering,ElectricalEngineering,BiomedicalEngineering,orotherSTEMdisciplines. + Advancedexperienceinsoftwareverification,qualityengineering,orvalidationofregulatedproducts,preferablyinthemedicaldevicedomain. **Desired** **Characteristics** **/** **Technical** **Expertise** **Technical** **Skills** + Extensiveexperienceinsoftwareverificationandtestautomationforcomplexsoftwareandmedicaldevicesystems. + Strongprogrammingskillsin Playwright and Type script, Python,orsimilarlanguageswithemphasisontestautomationandwhite-box and black box testingtechniques. + Experiencedevelopingandexecutingautomatedfunctional,integration,system,API,andregressiontests. + Experiencetestingwebservices,RESTAPIs,cloud-nativeapplications,anddistributedsystems. + Hands-onexperiencewithCI/CDtoolssuchasJenkins,AzureDevOps,GitHubActions,orequivalent. + Experiencewithtestmanagement,defecttracking,andrequirementsmanagementtools. + StrongunderstandingofLinux/UnixandWindowsenvironments.
+ Experiencewithvirtualization,containers,simulatedenvironments,hardware-in-the-loop(HIL),anddeviceintegrationtesting. + Strongknowledgeoftestautomationtechniquesincludingdata-driventesting,pairwisetesting,mocking,stubbing,faultinjection,andtesthooks. **Medical** **Device** **Domain** **Expertise** + ExperienceworkingwithinregulatedenvironmentsfollowingIEC62304,ISO13485,FDA,EUMDR,andrelatedstandards. + Understandingofsoftwareverificationandvalidationprocessesthroughoutthemedicaldevicelifecycle. + Experiencewithrequirementstraceability,riskcontrolsverification,cybersecuritytesting,andsoftwaresafetyclassifications. + FamiliaritywithDesignControls,DHF,DMR,CAPA,ChangeControl,andRiskManagementprocesses. + Experiencesupportingregulatorysubmissionsandauditreadinessactivitiesishighlydesirable. **Business** **Acumen** + Stronganalyticalandproblem-solvingcapabilitieswiththeabilitytoevaluatecomplextechnicalandqualitychallenges. + Experienceverifyingscalable,reliable,andhighlyavailablehealthcaresystemsandmedicaldevicesoftwaresolutions. + Abilitytodecomposecomplexverificationactivitiesintowell-definedtasksandproviderealisticeffortestimates. + Demonstratescustomer-focusedthinkingbyunderstandinghowproductquality,safety,reliability,andregulatorycomplianceimpactpatientoutcomesandclinicalworkflows. + Championsacultureofquality,patientsafety,continuousimprovement,andengineeringexcellenceacrosstheorganization **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 perks 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. #LI-Hybrid #LI-MP2 **Additional Information** **Relocation Assistance Provided:** Yes
📌 Staff Automation & Verification Lead (Bengaluru)
🏢 GE Healthcare
📍 Bengaluru