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
- Defectmanagemen

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