Scientist II

Location: Irvine CA

The Scientist2 - R&D will use knowledge of scientific techniques to contribute to validation or qualification of external devices to be reprocessed in company products and designing and developing safe and effective company products in compliance to new productdevelopmentprocedures.

Responsibilities:

UndersupervisionandgeneraldirectionandinaccordancewithallapplicablegovernmentlawsregulationsandASPpoliciesproceduresandguidelinesthisposition:

Performs various routine laboratory studies and assignments to support the validation and qualification of medical devices for reprocessing in ASP sterilization and disinfection systems within the ASP Technical Business Solutions Team(TBS)and other ASPfunctions.

Supportsor leads if neededdrafting of technical documents such as protocolstest reportsand technical reports using templates andexamplesfrompreviousstudies.

Contributes to the organization and directions of experiments and perform experiments under supervision to evaluate the development and assessment of new technologies for potential products following the regulatory guidelines/standards(FDATGAISOEU MDRetc.).

Ensures that projects and experiments are carefully and diligently conductedproperly recordedsatisfactorily completedandthoroughlysummarized.

to demonstrate research and development techniques.

Supports development of solutions to problems of limited to moderate scope and complexity through the exercise of judgment withindefinedpracticesandpoliciestodetermineappropriateactions.

Effectively communicates experiment status/testing results to laboratory equipment validation program.

SupportsOOSCAPAlaboratory investigationsand other investigatory processes ledby higher level scientists as needed.

Qualifications

BachelorsDegreeinaScientificfieldsuchasMicrobiologyorBiologywithover2yearsworkexperienceinalaboratoryorrelated environment.

understanding of compliance with applicable laboratory and safety procedure is required.

Knowledge of sterilizationdisinfectionand cleaning technologies for reprocessing of medical devices is strongly experience in a GxP-regulated industry and understanding of QSRFDAand ISO guidelines is preferred.

Workingexperiencewithsterilantsanddisinfectantsispreferred.