Senior Software Verification and Validation Engineer - Medical Device

MMR Consulting; City of Rochester (NY); On-site; USD 150,000 - 190,000; Full time

Job summary

MMRConsulting seeks an experienced Senior Software Verification and Validation Engineer to support medical devices, diagnostics systems, and laboratory instrumentation. The role emphasizes hands-on testing across hardware, software, and systems with cross-functional collaboration.

The ideal candidate will have a background in software and system verification/validation within regulated environments and be comfortable working across product development lifecycles. Rochester, NY onsite.

Qualifications

• Bachelor's degree or higher in Systems Engineering, Software Engineering, Computer Science, Electrical, Mechanical, Biomedical or related field.
• 15+ years of engineering, software V&V, systems V&V, medical device validation or regulated product development experience.
• Demonstrated experience with medical device, diagnostic, laboratory, or regulated products.
• Experience creating and maintaining requirements traceability and working in a structured quality environment.
• Strong technical documentation and troubleshooting abilities.

Responsibilities

• Develop and execute verification and validation strategies for medical devices and associated software.
• Translate requirements into test protocols, test cases, and test procedures; perform testing end-to-end.
• Establish traceability between requirements, risk controls, test cases, and results; perform defect investigation and resolution.
• Support technology transfer and new product introductions; collaborate with multidisciplinary teams.

Skills

Software verification

System verification

Software validation

Requirements traceability

Education

Bachelor's degree or higher in engineering/science

Tools

Jira

Windchill

HPALM/QualityCenter

SerenaQualityCenter

TFS (Azure DevOps)

Job description

MMRConsultingisanengineeringandconsultingfirmspecializinginthepharmaceuticalandbiotechnologyindustries.ItsservicesincludeEngineering,ProjectManagement,andValidation.

MMRConsultinghasofficesinCanada,USA,andAustralia.

WeareseekinganexperiencedSeniorSoftwareVerificationandValidation(V&V)Engineer tosupportthedevelopment,integration,verification,andvalidationofmedicaldevices,diagnosticsystems,laboratoryinstrumentation,andassociatedsoftware.Theidealcandidatewillhavestrongexperienceworkinginaregulatedmedicaldevice,diagnostic,laboratory,orlifesciencesenvironment,withabackgroundinsoftwareandsystemverificationandvalidation.

Thispositionwillsupportnewproductdevelopment,softwareandinstrumentintegration,technologytransfer,system-levelverification,softwarevalidation,andpost-launchproductsupport.Theengineerwillworkacrosshardware,software,systems,laboratory,quality,andengineeringfunctionsthroughouttheproductdevelopmentlifecycle.

Thisisahands-onV&Vposition,notarolefocusedsolelyonwritingtestdocumentation.

Full-time,onsitepositionintheRochester,NYarea.

Approximately70%oftherolewillinvolvehands-ontestingandvalidationactivities,withtheremainderinvolvingtestplanning,requirementsreview,documentation,dataanalysis,defectinvestigation,meetings,andcross-functionalengineeringactivities.

KeyResponsibilities

• Developandexecuteverificationandvalidationstrategiesformedicaldevices,diagnosticsystems,laboratoryinstruments,andassociatedsoftware.
• Developandexecutesoftwareandsystem-leveltestplans,testprotocols,testcases,andtestprocedures.
• Performverificationandvalidationthroughoutthemedicaldevice/productdevelopmentlifecycle.
• Translatesystem,software,anduserrequirementsintomeasurableverificationandvalidationactivities.
• Establishandmaintainrequirementstraceabilitybetweenrequirements,riskcontrols,testcases,testexecution,andtestresults.
• Performhands-ontestingofintegratedmedicaldevicesystems,instrumentation,software,andsubsystems.
• Executesoftwarevalidationtesting,includingfunctional,system,integration,regression,andnegativetestingasappropriate.
• Evaluatesoftware/hardwareinterfacesandsystemintegrationtoidentifyunexpectedbehavior,defects,orperformanceissues.
• Documenttestresults,deviations,anomalies,defects,andconclusionsinaccordancewithestablishedqualityprocedures.
• Troubleshootfailuresandunexpectedtestresultsandworkwithengineeringandsoftwaredevelopmentteamstoidentifyrootcausesandcorrectiveactions.
• Participateindefectinvestigation,resolution,retesting,andregressiontesting.
• Supportdesignverification,subsystemvalidation,systemvalidation,andpost-launchproductsupport.
• Generateandreviewrequirements,specifications,testprocedures,protocols,andvalidationdocumentationforcompletenessandtechnicalaccuracy.
• Reviewtheworkofotherengineersandprovidefeedbackregardingtestingquality,documentation,andrequirementstraceability.
• Supporttechnologytransferandnewproductintroductionactivities.
• Workwithmultidisciplinaryteamsconsistingofsoftware,systems,electrical,mechanical,laboratory,quality,regulatory,andproductdevelopmentpersonnel.
• Supportconfigurationandinstallationofsoftwareandcomputersystemsusedintesting.
• Participateinsoftware/testautomationactivitieswhereappropriate.
• Developorutilizescriptstosupportautomatedtesting,datacollection,testexecution,andanalysis.
• Adaptquicklytochangingprojectprioritiesandsupportmultipleprojectsasrequired.

SoftwareVerification&Validation

Thesuccessfulcandidateshouldhaveexperiencewithsoftwareverificationandvalidationwithinaregulatedproductdevelopmentenvironment.

Experienceworkingwithsoftwareembeddedinorsupportingmedicaldevices,diagnosticinstruments,laboratorysystems,orregulatedequipmentishighlydesirable.

• Softwarerequirementsverification
• Softwarefunctionaltesting
• Systemintegrationtesting
• System-levelverification
• Softwarevalidation
• Regressiontesting
• Userrequirementsverification
• Interfacetesting
• Installationandconfigurationtesting
• Automatedtesting
• Defectidentificationandtracking
• Testscriptdevelopment
• Testexecutionandresultsanalysis
• Requirementstraceability
• Risk-basedtesting
• Software/hardwareintegrationtesting

MedicalDeviceV&V

Candidatesshouldunderstandtheprinciplesofverificationandvalidationwithinaregulatedmedicaldeviceordiagnosticdevelopmentenvironment.

Experiencewiththefollowingishighlydesirable:

• Designverification
• Designvalidation
• Softwarevalidation
• Requirementsmanagement
• Traceability
• Risk-basedverification
• Testprotocoldevelopment
• Testexecution
• Defectmanagement
• Changecontrol
• Configurationmanagement
• Designcontrols
• Productdevelopmentlifecycleprocesses
• Post-marketorpost-launchproductsupport

RequiredQualifications

• Bachelor'sdegreeorhigherinSystems Engineering, Software Engineering, Computer Science, Electrical Engineering, Mechanical Engineering, Biomedical Engineering, or a related engineering/science discipline. Equivalentcombinationofeducationanddirectlyrelevantexperiencemaybeconsidered.
• 15+yearsofrelevantengineering,softwareV&V,systemsV&V,medicaldevicevalidation,orregulatedproductdevelopmentexperience;candidateswithstrongdirectlyapplicableexperiencemaybeconsideredwithfeweryears.
• Demonstratedexperiencewithmedicaldevice,diagnostic,laboratory,orotherregulatedproducts.
• Experiencedevelopingandexecutingverificationandvalidationtesting.
• Experiencecreatingandmaintainingrequirementstraceability.
• Experienceworkingwithinastructuredproductdevelopmentandqualityenvironment.
• Experiencetroubleshootingcomplexsoftware/hardwaresystems.
• Strongunderstandingofsoftwareverificationandvalidationmethodologies.
• Strongunderstandingofsystem-levelverificationandvalidation.
• Experiencetranslatingrequirementsintotestableacceptancecriteriaandtestcases.
• Strongtechnicaldocumentationskills.
• Stronganalyticalandtroubleshootingabilities.
• Experiencewithsoftwareandsystemintegrationtesting.
• Experiencewithtestautomationand/orautomateddatacollection.
• Basicprogrammingorscriptingexperienceusingtechnologiessuchas:
• Python
• VBA
• C/C++
• Otherscriptingorprogramminglanguages
• Experienceconfiguringandinstallingcomputersystemsandsoftwareusedfortesting.
• Understandingofcybersecurityconsiderationswithinmedicaldevices,laboratorysystems,orconnectedequipmentisbeneficial.

V&V/QualitySystemsExperience

Experiencewithregulateddevelopmentprocessesandqualitysystemsishighlydesirable,includingfamiliaritywith:

• Medicaldevicedesigncontrols
• Softwaredevelopmentlifecycleprocesses
• Requirementsmanagement
• Riskmanagement
• Configurationmanagement
• Changecontrol
• Defectmanagement
• Traceability
• Verificationandvalidationdocumentation
• Qualitymanagementsystems
• Regulatedproductdevelopment

Development&QualityTools

Experiencewithoneormoreofthefollowingispreferred:

• Jira
• Windchill
• HPALM/QualityCenter
• SerenaBusinessMashups
• AlignedElements
• MicrosoftTeamFoundationServer(TFS)

PreferredQualifications

• Experiencewithmedicaldevicesoftwarevalidation.
• Experiencevalidatingsoftwareembeddedwithinmedicaldevicesordiagnosticinstruments.
• Experiencewithlaboratoryinformationsystems,diagnosticsystems,orlaboratoryautomation.
• Experiencewithclinicalordiagnosticanalyzers.
• Experiencewithautomatedlaboratoryanalyzers,includingVITROS®systems,isaplus.
• Experiencewithsoftwaretestautomation.
• ExperiencewithPython,VBA,C/C++,orsimilarprogramming/scriptinglanguages.
• Experiencewithassay/instrumentintegration.
• Experiencesupportingtechnologytransferornewproductintroduction.
• Experienceworkinginaregulatedmedicaldevice,diagnostics,orlifesciencesenvironment.

KeyAttributes

Thesuccessfulcandidatewillbe:

• Hands-on:Comfortablespendingsignificanttimeexecutingtestsratherthanworkingexclusivelyondocumentation.
• Technicallystrong:Abletounderstandinteractionsbetweensoftware,hardware,instrumentation,andsystems.
• Detail-oriented:Abletoproduceaccurate,audit-readyV&Vdocumentationandmaintainrigoroustraceability.
• Analytical:Abletoinvestigatefailures,identifypotentialrootcauses,andworkwithdevelopmentteamstowardresolution.
• Adaptable:Comfortablemovingbetweenprojectsasprioritieschange.
• Collaborative:Abletoworkeffectivelywithsoftware,systems,engineering,quality,laboratory,andregulatoryteams.
• Independent:CapableofdevelopingandexecutingV&Vactivitieswithappropriatejudgmentandminimalsupervision.

Compensation starts from 150k/yr based on experience and expertise.

As part of our recruitment process, we may use technology-assisted tools,includingAI-enabledsystems,tosupportapplicationreviewandcandidateevaluation.Hiringdecisionsaremadewithhumanoversightandconsideration.

EqualEmploymentOpportunityandReasonableAccommodations

MMRConsultingisanequalopportunityemployer.Wecelebratediversityandarecommittedtocreatinganinclusiveenvironmentforallemployees.Ourhiringdecisionsarebasedonmerit,qualifications,andbusinessneeds.Wearecommittedtoworkingwithandprovidingreasonableaccommodationstoindividualswithdisabilitiesglobally.If,becauseofamedicalconditionordisability,youneedareasonableaccommodationforanypartoftheapplicationorinterviewprocess,pleaseletusknowthenatureofyourrequest.