Location: Irvine, CA
The Scientist 2 - 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 product development procedures.
Responsibilities:
Under supervision and general direction and in accordance with all applicable government laws, regulations and ASP policies, procedures, andguidelines, this position:
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 ASP functions.
Supports, or leads if needed, drafting of technical documents such as protocols, test reports, and technical reports using templates and examples from previous studies.
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 (FDA, TGA, ISO, EU MDR etc.).
Ensures that projects and experiments are carefully and diligently conducted, properly recorded, satisfactorily completed, and thoroughly summarized.
Follows prepared protocols and designed experiments to implement research studies. Expected to demonstrate research and development techniques.
Supports development of solutions to problems of limited to moderate scope and complexity through the exercise of judgment within defined practices and policies to determine appropriate actions.
Effectively communicates experiment status / testing results to others. Supports laboratory equipment validation program.
Supports OOS, CAPA, laboratory investigations, and other investigatory processes led by higher level scientists as needed.
Qualifications
Bachelor's Degree in a Scientific field, such as Microbiology or Biology with over 2 years work experience in a laboratory or related environment.
Master's Degree in a Scientific field, such as Microbiology or Biology with 0-2 years work in a laboratory or related environment. Strong understanding of compliance with applicable laboratory and safety procedure is required.
Knowledge of sterilization, disinfection, and cleaning technologies for reprocessing of medical devices is strongly preferred. Professional experience in a GxP-regulated industry and understanding of QSR, FDA, and ISO guidelines is preferred.
Working experience with sterilants and disinfectants is preferred.
Bonus or Equity
This position is also eligible for bonus as part of the total compensation package.
Pay Range
The salary range for this position (in local currency) is 81,190 - 135,585
