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.

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