Scientist 2, R&D Technical Business Solutions

About This Role

The Scientist 2, R&D will apply scientific techniques to validate external devices for reprocessing in company products and design safe and effective products according to development procedures. This role involves performing laboratory studies, drafting technical documents, and contributing to new technology evaluation.

Responsibilities

• Perform various routine laboratory studies and assignments to support the validation and qualification of medical devices for reprocessing in ASP sterilization and disinfection systems.
• Support, or lead if needed, drafting of technical documents such as protocols, test reports, and technical reports using templates and examples from previous studies.
• Contribute 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 regulatory guidelines.
• Ensure that projects and experiments are carefully and diligently conducted, properly recorded, satisfactorily completed, and thoroughly summarized.
• Follow prepared protocols and designed experiments to implement research studies.
• Demonstrate research and development techniques.
• Support development of solutions to problems of limited to moderate scope and complexity through the exercise of judgment within defined practices and policies.
• Effectively communicate experiment status / testing results to others.
• Support laboratory equipment validation program.
• Support OOS, CAPA, laboratory investigations, and other investigatory processes led by higher level scientists as needed.

Requirements

• Strong understanding of compliance with applicable laboratory and safety procedures

Qualifications

• Bachelor's Degree in a Scientific field, such as Microbiology or Biology
• 2+ years work experience in a laboratory or related environment with a Bachelor's; 0-2 years with a Master's degree.

Nice to Have

• Knowledge of sterilization, disinfection, and cleaning technologies for reprocessing of medical devices
• Professional experience in a GxP-regulated industry
• Understanding of QSR, FDA, and ISO guidelines
• Working experience with sterilants and disinfectants