Senior Software Verification and Validation Engineer - Medical Device
Listed on 2026-10-03
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Software Development
Software Testing
MMRConsultingisanengineeringandconsultingfirmspecializinginthepharmaceuticalandbiotechnologyindustries.
Itsservicesinclude Engineering,Project Management,and Validation.
MMRConsultinghasofficesin
Canada,USA,and Australia.
Weareseekinganexperienced Senior Software Verification and Validation (V&V)
Engineer tosupportthedevelopment,integration,verification,andvalidationofmedicaldevices,diagnostic systems,laboratory instrumentation,andassociatedsoftware.
Theidealcandidatewillhavestrongexperienceworkinginaregulatedmedicaldevice,diagnostic,laboratory,orlifesciencesenvironment,withabackgroundinsoftwareandsystemverificationandvalidation.
Thispositionwillsupportnewproductdevelopment,softwareandinstrumentintegration,technology transfer,system-level verification,software validation,andpost-launchproductsupport.
Theengineerwillworkacrosshardware,software,systems,laboratory,quality,andengineeringfunctionsthroughouttheproductdevelopmentlifecycle.
Thisisahands-onV&Vposition,notarolefocusedsolelyonwritingtestdocumentation.
Full-time,onsitepositioninthe
Rochester,NYarea.
Approximately
70% oftherolewillinvolvehands-ontestingandvalidationactivities,withtheremainderinvolvingtestplanning,requirements review,documentation,data analysis,defect investigation,meetings,andcross-functionalengineeringactivities.
- Developandexecuteverificationandvalidationstrategiesformedicaldevices,diagnostic systems,laboratory instruments,andassociatedsoftware.
- Developandexecutesoftwareandsystem-leveltestplans,test protocols,testcases,andtestprocedures.
- Performverificationandvalidationthroughoutthemedicaldevice/productdevelopmentlifecycle.
- Translate system,software,anduserrequirementsintomeasurableverificationandvalidationactivities.
- Establishandmaintainrequirementstraceabilitybetweenrequirements,riskcontrols,testcases,test execution,and testresults.
- Perform hands-ontestingofintegratedmedicaldevicesystems,instrumentation,software,and subsystems.
- Executesoftwarevalidationtesting,including functional,system,integration,regression,andnegativetestingasappropriate.
- Evaluate software/hardwareinterfacesandsystemintegrationtoidentifyunexpectedbehavior,defects,orperformanceissues.
- Document testresults,deviations,anomalies,defects,andconclusionsinaccordancewithestablishedqualityprocedures.
- Troubleshootfailuresandunexpectedtestresultsandworkwithengineeringandsoftwaredevelopmentteamstoidentifyrootcausesandcorrectiveactions.
- Participateindefectinvestigation,resolution,retesting,andregressiontesting.
- Supportdesignverification,subsystem validation,system validation,andpost-launchproductsupport.
- Generateandreviewrequirements,specifications,test procedures,protocols,andvalidationdocumentationforcompletenessandtechnicalaccuracy.
- Reviewtheworkofotherengineersandprovidefeedbackregardingtestingquality,documentation,andrequirementstraceability.
- Supporttechnologytransferandnewproductintroductionactivities.
- Workwithmultidisciplinaryteamsconsistingofsoftware,systems,electrical,mechanical,laboratory,quality,regulatory,andproductdevelopmentpersonnel.
- Supportconfigurationandinstallationofsoftwareandcomputersystemsusedintesting.
- Participateinsoftware/testautomationactivitieswhereappropriate.
- Developorutilizescriptstosupportautomatedtesting,data collection,test execution,and analysis.
- Adaptquicklytochangingprojectprioritiesandsupportmultipleprojectsasrequired.
Thesuccessfulcandidateshouldhaveexperiencewithsoftwareverificationandvalidationwithinaregulatedproductdevelopmentenvironment.
Experienceworkingwithsoftwareembeddedinorsupportingmedicaldevices,diagnostic instruments,laboratory systems,orregulatedequipmentishighlydesirable.
- Softwarerequirementsverification
- Softwarefunctionaltesting
- Systemintegrationtesting
- System-level verification
- Software validation
- Regression testing
- Userrequirementsverification
- Interface testing
- Installationandconfigurationtesting
- Automated testing
- Defectidentificationandtracking
- Testscriptdevelopment
- Testexecutionandresultsanalysis
- Requirements traceability
- Risk-based testing
- Software/hardwareintegrationtesting
DeviceV&V
Candidatesshouldunderstandtheprinciplesofverificationandvalidationwithinaregulatedmedicaldeviceordiagnosticdevelopmentenvironment.
Experiencewiththefollowingishighlydesirable:
- Design verification
- Design validation
- Software validation
- Requirements management
- Traceability
- Risk-based verification
- Testprotocoldevelopment
- Test execution
- Defect management
- Change control
- Configuration management
- Design controls
- Productdevelopmentlifecycleprocesses
- Post-marketorpost-launchproductsupport
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