Scientist I

Location: Irvine, CA

The Scientist I 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 and guidelines, 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 and communicate results to stakeholders, as needed.
• Expected to 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 the regulatory guidelines / standards (FDA, TGA, ISO 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 execute research studies under supervision to support product development from feasibility to final product verification / validation
• 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.
• Requires a limited to full use of application of basic to standard principles, theories, concepts, and techniques
• Supports laboratory equipment validation program
• Supports OOS, CAPA, laboratory investigations, and other investigatory processes led by higher level scientists as needed.
• Must be able to provide training to other laboratory personnel in execution of testing procedures
• Responsible for communicating business related issues or opportunities to next management level.
• Performs other duties assigned as needed

Other Duties:

• Provide support to other programs and project teams that require testing
• Support team focused on identifying and implementing process level efficiencies
• Support in maintaining awareness of the advances and needs in sterilization / disinfection, microbiology and biocompatibility
• Contribute to building extra ordinary team environment

Qualifications

Education:

• Bachelor's Degree in a scientific discipline. such as Microbiology, Biology, or a closely related field.
   

Years of Related Experience:

• 0-2 years in laboratory or related environment

Knowledge, Skills, Abilities, Certifications/Licenses, and Affiliations:
(Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.)

• 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
• The successful candidate must be self-driven, have strong critical thinking and problem-solving skills, and capable of working independently or in a team.
• Must possess effective oral and written communication skills as well as demonstrate the ability to effectively function in a cross-functional team environment
• Working experience with sterilants and disinfectants is preferred
• Working experience with medical washer-disinfectors or sterilizers intended for reprocessing of medical devices is preferred
• Experience in validation or qualifying medical devices for reprocessing in medical washer-disinfectors or sterilizers is preferred
• Working knowledge of designs and features of medical devices is preferred

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 design, and healthcare safety solutions.

We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in software-powered workflow solutions, data-driven intelligence, AI-powered automation, and other disruptive technologies. We’re a force for progress, working alongside our customers and partners to solve challenges on a global scale, from workplace safety in the most demanding conditions to groundbreaking sustainability solutions.

We are a diverse team 18,000 strong, united by a dynamic, inclusive culture and energized by limitless learning and growth. We use the proven Fortive Business System (FBS) to accelerate our positive impact. 

At Fortive, we believe in you. We believe in your potential—your ability to learn, grow, and make a difference. 

At Fortive, we believe in us. We believe in the power of people working together to solve problems no one could solve alone. 

At Fortive, we believe in growth. We’re honest about what’s working and what isn’t, and we never stop improving and innovating.

Fortive: For you, for us, for growth.