Sr. Biomedical Engineer Job at Development Resource Group, Minnesota

  • Development Resource Group
  • Minnesota

Job Description

SeekingaBiomedicalEngineertoberesponsibleforevaluatingthesafetyandcompatibilityofmedicaldeviceswithbiologicalsystems.TheroleinvolvesplanningandplacingbiocompatibilitytestinginaccordancewithISO10993standards,regulatoryguidelines,andriskassessmentprinciples.Thisindividualcollaborateswithcross-functionalteamstoensurematerialsmeetsafetyrequirements.Thisindividualanalyzesdata,preparestechnicalreports,andsupportsregulatorysubmissions.Thispositionmayalsobeinvolvedindevelopingstrategiesfornewproductsandaddressingbiocompatibilityrelatedissuesduringproductdevelopmentandpost-marketactivities.

POSITIONRESPONSIBILITIES:
DesignandexecutebiocompatibilityassessmentplansandreportsinaccordancewithISO10993andregulatoryrequirements.

Interfacewithlaboratoriestocoordinatetestingactivities,ensurecompliance,andresolveanytechnicalissues.

Reviewandinterpretlaboratorytestresults;documentfindingsintechnicalreportsandregulatorysubmissions.

Supportproductdevelopmentlifecycleactivities,includingdesignchangesandpost-marketsurveillance,fromabiocompatibilityperspective.

Staycurrentwithevolvingglobalbiocompatibilitystandards,guidancedocuments,andregulatoryexpectationstoensureongoingcompliance.

RequiresaUniversityDegreeandminimumof4yearsofrelevantexperience,oradvanceddegreewithaminimumof2yearsrelevantexperience.

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