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

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