ProjectEngineerDesign

Company: CeQurCorporation Location: Marlborough,MA 01752 Department: Engineering ExperienceLevel: ProjectManager

Status: FullTime,Employee Occupations: ProductDevelopmentEngineer Design Industry: MedicalDevices

JobDescription Located in Marlborough, MA,CeQuris an earlystage medical device company that is bringing disposable medical devices from R&D to manufacturing for commercialization. We are a team of entrepreneurially minded engineers, and scientists, working in close collaboration to understand the disease of diabetes and are committed to create patient focusedmanagedcaresolutionstoimproveeverydaylivesofdiabetespatients. The companys Research & Development around our core technology of precision microfluidic control is located in Denmark. The operational headquarters along with the disposable product development group is located in Marlborough, MA. CeQur is now looking for an engineer to optimize the design of some portions of the product to improve manufacturability and incorporate learnings from our earlier testing and clinical use. The candidate will be a product designer with a strong background in designing plastic parts. They will need to understand and work closely with our plastic molding vendors. The candidate will also have a background in program management, laying out and communicating plans and work flow, anticipating and addressing issues, and communicating with team members and management members on the respective project. This position will be based in Marlborough requiring travel to Denmarkaswellassuppliers. The ideal candidate will have a proven track record demonstrating our core values of responsibility, team work, customer focus, continuous improvement and employee engagement. The candidate will also have experience demonstrating the skills of technical leadership with plastic part design, creativity in design and problem solving, and designformoldingandassembly. Responsibilities ForaspecificsubsystemofPaQ,assumeproductdesignresponsibilitiesandleadacrossfunctionalteam throughallstagesofproductdevelopment Solicitandapplyinputsfrommedicalthoughtleaders,marketing,andotherstakeholderstodefineproduct specifications Developsolutionstodesignproblemsthroughtheapplicationofengineeringprinciples,analysis,andempirical methods Proactivelyanticipatetechnicalissuesandwithinputfromtheprojectteam,createandexecuteprojectplansto meetteamobjectives. ModelcomplexcomponentsandassembliesinProEandSolidWorks AnalyzecomplexcomponentsandassembliesusingsuchtechniquesasRSStoleranceanalysistechniquesand finiteelementanalysis Designprototypesforproofofconcept Developmethodsandprotocolsforproductverificationandvalidationtesting CompileDesignHistoryFilespercompanypoliciesandprocedures Leadprocessrelateddesigntaskstosupportpilotmanufacturing Enhancetheintellectualpropertypositionofthecompanyviainventiondisclosuresandpatentapplications Qualifications

Goodunderstandingofinjectionmoldtoolingandassociatedmoldingprocesseswithemphasisoninnovated approachestoimprovequality,assembly,andefficiency Experienceworkingwithoutsourcedmoldtoolingandmoldingvendors ExperiencedinprojectmanagementincludingschedulingtoolssuchasMSProject Proventrackrecordofworkingwithinjectionmoldingengineerstoconductstackingtoleranceanalysisand developdesignssuitableformanual,semiautomated,andeventualautomatedassemblyoffinishedproducts Knowledgeandinvolvementindevelopingandimplementingoverallvaluestreamprocesstoestablishreliable processesandproceduresformanufacturing(moldingandassembly),packaging,andsterilizationofmedical devices SolidunderstandingofproductengineeringandCADdesignandanalysistoolssuchasProE,SolidWorks,with addonapplicationstosupportspecificdetailedanalysis Experiencedinworkinginamatrixmanagementorganizationtoestablishinitialpilotphaseoflowvolume manufacturingoperationsandscalabilitytofullscalemanufacturing Ateamorientedplayerwhocollaboratesandcommunicateseffectivelywithlocalandinternationalteam membersinacrossfunctional,multicultural,interdisciplinaryenvironment ExcitedaboutbeingakeyteammembermakingadirectandpositiveimpactontheCompany Lookingtoworkinanextremelydynamicandfastpacedenvironment,andyouarepreparedtomeetaggressive developmentmilestones Knowledgeofthestagegateprocessandstagereviewsusedinproductdevelopmentprograms

Requirements

B.S.degreeinmechanicalengineeringrequired,M.S.isaplus Minimumof10yearsofmedicaldeviceproductdevelopmentexperience StrongunderstandingofDesignforManufacturingandAssembly(DFMA) Specificexperiencewithplastic/polymermaterialsandmanufacturingprocessesusedinthemanufactureof medicaldeviceproducts Demonstratedskillsin3DCAD(AutoCAD,ProE,etc) ExtensiveexperiencewithMedicalIndustryofDesignControlprocedures,processvalidationactivities,Quality Assurance,Validation,qualifyingprocesses,andrelatedDocumentationprotocolsandprocedures Provenabilitytoleadsmallteamstomeetdesiredresults ExperienceandknowledgeinmanufacturingproductsunderISO13485,andFDA/GMPproceduresisaplus DemonstratedTeamplayerwithexcellentwrittenandverbalcommunicationskills ExperienceandknowledgeofLeanManufacturingand/orSixSigmaaplus Willingnesstotravelinternationallyanddomestically LegallyabletoworkintheUnitedStates

Reportsto:ChiefTechnicalOfficer Fulltime;positionislocatedat734ForestStreet,Suite100,Marlborough,MA01752.Pleaseemailresumeto careers@cequr.net,andreferencejobcodeQMES04.Nophonecallsplease.