Thisisafull-time,onsitepositioninthe Rochester,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.

MMRConsultinghasofficesin Canada,USA,and Australia.

Weareseekinganexperienced Senior Software Verificationand Validation(V&V;)Engineertosupportthedevelopment,integration,verification,andvalidationofmedicaldevices,diagnosticsystems,laboratoryinstrumentation,

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-fun

Key Responsibilities

- 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.

Software Verification&Validation;

Thesuccessfulcandidateshouldhaveexperiencewithsoftwareverificationandvalidationwithinaregulatedproductdevelopmentenvironment.

Experiencemayinclude:

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

Medical DeviceV&V;

Candidatesshouldunderstandtheprinciplesofverificationandvalidationwithinaregulatedmedicaldeviceordiagnosticdevelopmentenvironment.

Experiencewiththefollowingishighlydesirable:

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

Required Qualifications

- Bachelor'sdegreeorhigherin Systems 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;/Quality Systems Experience

Experiencewithregulateddevelopmentprocessesandqualitysystemsishighlydesirable,includingfamiliaritywith:

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

Development&Quality; Tools

Experiencewithoneormoreofthefollowingispreferred:

- Jira
- Windchill
- HPALM/Quality Center
- Serena Business Mashups
- Aligned Elements
- Microsoft Team Foundation Server(TFS)

Preferred Qualifications

- Experiencewithmedicaldevicesoftwarevalidation.
- Experiencevalidatingsoftwareembeddedwithinmedicaldevicesordiagnosticinstruments.
- Experiencewithlaboratoryinformationsystems,diagnosticsystems,orlaboratoryautomation.
- Experiencewithclinicalordiagnosticanalyzers.
- Experiencewithautomatedlaboratoryanalyzers,includingVITROSsystems,isaplus.
- Experiencewithsoftwaretestautomation.
- Experiencewith Python,VBA,C/C++,orsimilarprogramming/scriptinglanguages.
- Experiencewithassay/instrumentintegration.
- Experiencesupportingtechnologytransferornewproductintroduction.
- Experienceworkinginaregulatedmedicaldevice,diagnostics,orlifesciencesenvironment.

Key Attributes

Thesuccessfulcandidatewillbe:

- Hands-on: Comfortablespendingsignificanttimeexecutingtestsratherthanworkingexclusivelyondocumentation.
- Technicallystrong: Abletounderstandinteractionsbetweensoftware,hardware,instrumentation,andsystems.
- Detail-oriented: Abletoproduceaccurate,audit-readyV&Vdocumentationandmaintainrigoroustraceability.;
- Analytical: Abletoinvestigatefailures,identifypotentialrootcauses,andworkwithdevelopmentteamstowardresolution.
- Adaptable: Comfortablemovingbetweenprojectsasprioritieschange.
- Team-oriented: 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.

Equal Employment Opportunityand Reasonable Accommodations

MMRConsultingisanequalopportunityemployer. Wecelebratediversityandarecommittedtocreatinganinclusiveenvironmentforallemployees. Ourhiringdecisionsarebasedonmerit,qualifications,andbusinessneeds. Wearecomm

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