Senior Engineer, Design Assurance
- Work arrangement
- Remote
- Occupation
- Software & IT
- Location
- India
- Compensation
- Not disclosed
- Apply by
- April 10, 2027
About this role
Accountabilities
ManageandmaintainDesignHistoryFiles(DHF),ensuringdocumentationiscomplete,accurate,traceable,andcompliantwithapplicablequalityrequirements.
ConductregularDHFauditstoidentifygaps,maintaindocumentationintegrity,andsupportongoingregulatorycompliance.
Reviewandapprovedesignrequirements,ProductDesignReviews(PDR),requirementsmatrices,andengineeringchangeorders,ensuringappropriateverificationandvalidation(V&V)activitiesaredefinedandcompleted.
Collaboratewithcross-functionalteamstodevelop,review,andmaintainriskmanagementfilesandrelateddocumentation,includingensuringriskassessmentsareupdatedalongsidedesignchanges.
ReviewandapproveTestMethodValidation(TMV)protocolsandreports,includingGageRepeatabilityandReproducibility(GageR&R),toconfirmmeasurementsystemsarereliablebeforeV&Vexecution.
Monitorpost-marketfeedbackforearly-stageproducts,assessfieldperformance,andpreparePost-MarketSurveillance(PMS)reportsandfieldfeedbackreviews.
Investigatenonconformancereports(NCRs),performrootcauseanalysis,andsupportcorrectiveactionsandcontinuousqualityimprovement.
Providedesignqualityguidancetoengineeringandotherstakeholders,promotingcompliancewithestablisheddesigncontrolsandqualitymanagementprocesses.
Supportcontinuousimprovementinitiativesthatstrengthenproductquality,riskmanagement,andregulatoryreadiness.
Atleast3yearsofexperienceinQualityEngineeringwithinthemedicaldeviceindustry,specificallyinDesignQualityorDesignAssurance.
StrongworkingknowledgeofFDA21CFRPart820,ISO13485,andISO14971requirementsandtheirapplicationtomedicaldevicedevelopment.
Demonstratedexperiencecreating,reviewing,andmaintainingDesignHistoryFiles(DHF),riskmanagementdocumentation,DesignFailureModeandEffectsAnalysis(DFMEA),UseFailureModeandEffectsAnalysis(UFMEA),andProcessFailureModeandEffectsAnalysis(PFMEA).
Experiencereviewingverificationandvalidation(V&V)protocolsandreports,aswellasTestMethodValidationdocumentation,includingGageR&Rstudies.
StrongabilitytointerpretcomplexengineeringdrawingsandapplyGeometricDimensioningandTolerancing(GD&T)principles.
Experienceinvestigatingnonconformances,conductingrootcauseanalysis,andsupportingqualityimprovementactivities.
ProficiencyinMicrosoftOfficeapplicationsandtechnicaldocumentation.
Excellentcommunication,analyticalthinking,problem-solving,organizational,andleadershipskills,withtheabilitytocollaborateeffectivelyacrossmultidisciplinaryteams.
Willingnessandabilitytotravelinternationallyonoccasion.
SixSigmaGreenBeltcertification.
CertifiedQualityEngineer(CQE)credential.
Abachelor'sdegreeinBiomedicalEngineering,MechanicalEngineering,ElectricalEngineering,orarelatedtechnicaldiscipline.
Competitivebenefitspackagedesignedtosupportemployeehealth,financialsecurity,andoverallwell-being.
Healthcarebenefitsandotheremployeesupportprograms,withspecificofferingsdeterminedbylocation.
Paidtimeofftosupportwork-lifebalanceandpersonalwell-being.
Professionaldevelopmentopportunitiesinmedicaldevicequalityengineering,designassurance,andregulatorycompliance.
Cross-functionalcollaborationwithengineering,regulatory,clinical,andmanufacturingprofessionals.
Continuousimprovementculturethatencouragesinnovation,knowledgesharing,andthedevelopmentoftechnicalexpertise.
Meaningfulworkcontributingtothesafety,reliability,andeffectivenessofmedicaltechnologiesthatsupportpatientcare.