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 current 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.

📌 Senior Software Verification and Validation Engineer - Medical Device (Vaughan)
🏢 MMR Consulting
📍 Vaughan