Sr. Supplier Engineer

Duration:12

Months Contract

Location:

Arden Hills,MN

Possibleattemptohireforrightindividualandifbudgetallows.

Interviews:1-2teams.

Thispersonmustbeabletotravel5-10% globally(possibly

Sweden,China,Finland,alsolocal.)Approximately5-10tripperyr.

ONSITE-AH.

Business Job Title :Senior Supplier Engineer Asa Senior Supplier Engineer ,you’llbethebridgebetween

Cardiac

Diagnostics cutting-edgedesignleadingtheintegrationofnewandexistingtechnologiesintoglobalsupplychain.

Yourworkwilldirectlyimpactthereliability,scalability,andspeedatwhichlife-changingdevicesreachpatients.

• Asthetechnicallead,you’llworkwith
  
  R&D,Quality,Operations,andRegulatoryteammemberstointegrate
  
  OEMandsub-systemsupplierdesignsalongwithsuppliedcomponentsinto
  
  CDx’sproductstoensurecompliance,performance,andsafetyrequirementsaremet.
  
  Thisrolehasawidescopeofresponsibilitiesrangingfromensuringsupplierdesignassurance,supplierproductdevelopmentintegrationassurance,andthird-partymanufacturingassurance.
• Youwillapplystrongengineeringfundamentalstoanalyzesupplieddesigns,assesssupplierprocesscapabilities,anddrivecorrectiveandpreventiveactionsthatenhancequality,reliability,andmanufacturability.
  
  At,collaborationacrossdisciplinesiskeytooursuccess.
  
  Thispositionfollowsahybridworkmodel,requiring on-sitepresencewithkeypartnersatleastthreedaysperweektosupportdesignassurance,suppliertechnicaldiscussions,andcross-functional problem-solving.

Responsibilitieswillinclude:

• Working with Medical Device OEM,sub-systemandcomponentsupplierstoidentifysupplierspecificationswiththeendgoalofsuccessfullyintegratingsupplieddesignsandcomponentsinto
  
  CDx’sdevelopmentandmanufacturingprocesses.
• Partnering with
  
  R&D,Design Assurance,Manufacturing Engineering,Operations Quality,and
• Project Managementtoexecutesuppliercontroldeliverablesaccordingtoprogramneeds,suchaspurchasedmaterialqualifications,supplier-drivenchangeassessments,supplierdesignorcapabilityimprovementprojects,orregulatedcomplianceassessments.
• Generatingandreviewingqualityplans,agreements,product specifications,component qualifications,design verification/validations,andprocessvalidations.
• Investigatingcomplaintsandmanagingsupplierinvestigationsforbothdesignandmanufacturing-related issues.
• Participatinginsupplierauditstoassessdesignandmanufacturingcompliancetoregulatorystandardsand
  
  CDxagreedspecificationrequirements.
  
  Auditactivitiesincludetheevaluationofauditobservationsandfindings,reporting,follow-up,andconfirmationoffollow-upactions.
• Actingasatechnicalexperttoensurerepeatableandreproduciblequality/reliabilityduringthelifeoftheproduct.
• Investigatingandevaluatingsuppliersofnewandexistingtechnologiesforuseinfutureproductsortoimprovequality/reliabilityofcurrentproducts.
• Participatinginriskassessmentofsuppliercapability,supplierdesignsandsuppliersupplyprocessestosupportplanningandexecutionincludingserviceriskmitigationmeasurestoensurecontinuityofsupplyforCoordinatingallphasesofsupplierengineeringworkincludingcontentforprojectsandcommunicatingemergingissuesandrecoveryplanswithsiteleadershipandstakeholderstogainresourcesandsupport
• Demonstratingaprimarycommitmenttopatientsafetyandproductqualitybymaintainingcompliancetothe Quality Policyandallotherdocumentedqualityprocessesandprocedures

Required Qualifications:

• Bachelor’sdegreeinengineeringorrelateddiscipline
• Minimum5yearsoftechnicalexperienceworkingin Medical Devicedevelopmentprocesses
• Experienceindesigncontrols,risk management,process validation,andCAPA
• Abilitytotravel5-10% globally(possibly
  
  Sweden,China,Finland,alsolocal.)Approximately5-10tripperyr.

Preferred Qualifications
:

• Designassuranceexperiencewith7+yearsworkingin
  
  Medical Device development
• Experienceworkingwithsuppliersandfamiliarwiththeapplicationofdesigncontrolsandsupplier
• controlsasper
  21
  
  CFR
  820andMDR
• Auditorofqualitysystemsexperience(ISO
  13485orsimilar)
• Self-drivenandresultsorientedwithstrongdataanalyticsandcriticalthinkingskills
• Experiencemanagingprojectsandworkingwithcross-functionalteamstodrivedeliverables
• Organizedanddetail-orientedwithabilitytoprioritizeandmanagemultipleprojects
• Stronginterpersonalandcommunicationskillswithabilitytodevelopinternalandexternalrelationships

About

USTechSolutions:

USTechSolutionsisaglobalstaffaugmentationfirmprovidingawiderangeoftalenton-demandandtotalworkforcesolutions.

Tolearnmoreabout

USTechSolutions,pleas

USTech Solutionsisan Equal Opportunity Employer .Allqualifiedapplicantswillreceiveconsiderationforemploymentwithoutregardtorace,color,religion,sex,sexual orientation,gender identity,national origin,disability,orstatusasaprotectedveteran.