Scientist 2, R&D Technical Business Solutions
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Job Location:
Irvine, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Scientist 2 R&D Technical Business Solutions
Description
Scientist2R&Dwilluseknowledgeofscientifictechniquestocontributetovalidationorqualificationofexternaldevicestobereprocessedincompanyproductsand designinganddevelopingsafeandeffectivecompanyproducts incompliancetonewproductdevelopmentprocedures.
Responsibilities
Under supervision and general direction and in accordance with all applicable government laws regulations and ASP policies procedures and guidelines this position.
Performsvariousroutinelaboratorystudiesandassignmentstosupportthevalidationandqualificationofmedical devicesforreprocessinginASPsterilizationanddisinfectionsystemswithintheASPTechnicalBusinessSolutions Team(TBS)andotherASPfunctions.
Supports or leads if needed drafting of technical documents such as protocols test reports and technical reports using templates and examples from previous studies.
Contributestotheorganizationanddirectionsofexperimentsandperformexperimentsundersupervisiontoevaluatethedevelopmentandassessmentofnewtechnologies forpotentialproductsfollowingtheregulatory guidelines/standards(FDATGAISOEUMDRetc.).
Ensuresthatprojectsandexperimentsarecarefullyanddiligentlyconductedproperlyrecordedsatisfactorilycompletedandthoroughlysummarized.
Followspreparedprotocolsanddesignedexperimentstoimplementresearchstudies.
Expected to demonstrate research and development techniques.
Supportsdevelopmentofsolutionstoproblemsoflimitedtomoderatescopeandcomplexitythroughtheexerciseofjudgmentwithindefinedpracticesandpoliciesto determineappropriateactions. Effectivelycommunicatesexperimentstatus/testingresultstoothers.
Supports laboratory equipment validation program.
Supports OOS CAPA laboratory investigations and other investigatory processes led by higher level scientists as needed.
Qualifications
BachelorsDegreeinaScientificfieldsuchasMicrobiologyorBiologywithover2yearsworkexperienceinalaboratoryorrelatedenvironment. MasterʼsDegreeinaScientificfieldsuchasMicrobiologyorBiologywith0-2yearsworkinalaboratoryorrelatedenvironment.
Strong understanding of compliance with applicable laboratory and safety procedure is required.
Knowledgeofsterilizationdisinfectionandcleaningtechnologiesforreprocessingofmedicaldevicesisstronglypreferred. ProfessionalexperienceinaGxP-regulatedindustryandunderstandingofQSRFDAandISOguidelinesispreferred.
Working experience with sterilants and disinfectants is preferred.
Required Experience:
IC
Key Skills
- Laboratory Experience
- Vendor Management
- Design Controls
- C/C++
- FDA Regulations
- Intellectual Property Law
- ISO 13485
- Research Experience
- SolidWorks
- Research & Development
- Internet Of Things
- Product Development
About Company
Fortive Corporation Overview Fortive’s essential technology makes the world stronger, safer, and smarter. We accelerate transformation across a broad range of applications including environmental, health and safety compliance, industrial condition monitoring, next-generation product d ... View more
