Scientist II
Advanced Sterilization Products · Irvine, CA · 1 wk ago
AnalystFull-time
Duties And Responsibilities
- Perform experiments to support the development and assessment of new technologies, following applicable regulatory standards (e.g., FDA, ISO).
- This may include biological, chemical, and mechanical studies of materials, medical devices, cleaning agents, disinfectants, sterilants, and processing technologies.
- Contribute to the design and direction of experiments by developing methodologies, and reviewing, analyzing, and interpreting data.
- Execute research studies under supervision following established protocols, supporting product development from feasibility through final verification and validation.
- Manage independent projects under the guidance of process leaders and project facilitators.
- Organize and analyze data, prepare reports, and communicate experiment status and results to others.
- Provide technical support, maintain laboratory readiness, and train personnel in scientific methods, equipment use, and procedures as needed.
- Demonstrate strong documentation practices, adherence to regulatory and quality standards, and contribution to a culture of scientific integrity and operational excellence.
- Communicate business-related issues or opportunities to the next level of management, and perform other duties as assigned.
Education And Experience
- Bachelor's degree in a scientific discipline (e.g., chemistry, biochemistry, microbiology, biology, materials science, or engineering), or equivalent practical experience.
- A graduate degree is preferred.
- At least 2 years of relevant scientific, laboratory, or technical experience in regulated or quality-focused environments, or equivalent demonstrated competencies.
Knowledge, Skills, And Abilities
- Strong understanding of, and ability to comply with, applicable laboratory and safety procedures (required).
- Self-driven, with strong critical-thinking and problem-solving skills, and able to work both independently and in a cross-functional team (required).
- Effective oral and written communication skills (required).
- Knowledge of sterilization, disinfection, and cleaning technologies for reprocessing medical devices (strongly preferred).
- Experience in a GxP-regulated industry, with knowledge of QSR, FDA, and ISO guidelines (preferred).
- Hands-on experience with sterilants, disinfectants, and medical washer-disinfectors or sterilizers, including validating or qualifying devices for reprocessing (preferred).
- Working knowledge of medical device designs and material compatibility with high-level disinfectants or sterilants (preferred).
- Proficiency with Minitab and Train-the-Trainer / Training Within Industry (TWI) experience (preferred).
Working Conditions
- Domestic travel up to 10% as required.
- Ability to lift up to 30 lbs as needed for laboratory operations.