Senior Software Verification and Validation Engineer - Medical Device

Thisisafull-time,onsitepositionintheRochester,NYarea. Candidates must be willing and able to commute to the facility daily.

MMR Consulting is an engineering and consulting firm specializing in the pharmaceutical and biotechnology industries. Its services include Engineering, Project Management, and Validation.

MMRConsultinghasofficesinCanada,USA,andAustralia.

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

This position will support new product development, software and instrument integration, technology transfer, system-level verification, software validation, and post-launch product support. The engineer will work across hardware, software, systems, laboratory, quality, and engineering functions throughout the product development life cycle.

Thisisahands-onV&Vposition,notarolefocusedsolelyonwritingtestdocumentation.

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.

Experiencemayinclude:

• 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. Equivalencombinationofeducationanddirectlyrelevantexperiencemaybeconsidered.
• 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,includingVITROSsystems,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, including AI-enabled systems, to support application review and candidate evaluation. Hiring decisions are made with human oversight and consideration.

EqualEmploymentOpportunityandReasonableAccommodations

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