R&D Scientist II, Chemistry

Fortive•Irvine, CA

About The Position

Under moderate supervision and general direction, and in accordance with all applicable government laws, regulations, and ASP policies, procedures, and guidelines, this position: Plans and executes experiments and project tasks in support of new technologies associated with cleaning, disinfection, or sterilization of medical instruments. Demonstrates research and development techniques; independently determines how to set up and execute experiments and analyses. Follows prepared protocols and designed experiments to execute research studies under limited supervision to support new product development from feasibility to final product verification/validation. Performs routine and complex testing in compliance with laboratory test methods and procedures to support timely delivery of tasks related to new product development and product life‑cycle management. Conducts qualitative and quantitative chemical analysis of raw materials and finished goods. Develops appropriate protocols, executes studies, organizes data, performs data analysis, and prepares reports. Supports the 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 action. Participates in and supports new product development projects through feasibility work to pilot production. Communicates experiment status and testing results effectively and comprehensively to others. Supports and coordinates equipment qualifications and maintains laboratory instruments in their qualified state, as well as troubleshoots instrumentation in the event of issues. Supports OOS, NC, and CAPA investigations for higher‑level scientists as needed. Provides training to other laboratory personnel in the execution of testing procedures. Responsible for communicating business‑related issues or opportunities to the next management level. Provides support to other programs and project teams that require chemistry testing and technical expertise. Supports teams focused on identifying and implementing process‑level efficiencies. External Interactions Responds to questions from ASP customers, government agencies, or auditors according to standard operating procedures. Supports communication with external suppliers, service providers, and manufacturers. All employees must comply with applicable laws, regulations, standards, and ASP policies and procedures. This job description is intended to convey information essential to understanding the scope of the position and is not an exhaustive list of duties or responsibilities. Employees may perform other job‑related tasks as assigned by their supervisor. Reasonable accommodations may be made for individuals with disabilities.

Requirements

Bachelor's or Master's degree in Chemistry or a closely related field.
A Bachelor's degree in Chemistry or a closely related field with more than 3 years of applicable experience, or a Master's degree in Chemistry or a closely related field with 1-3 years of applicable experience, including:
Experience in the medical device or other GxP‑regulated industry.
Hands‑on experience in a laboratory environment and analytical chemistry.
Strong understanding of compliance with applicable laboratory and safety procedures is required.
Excellent hands‑on experience in an R&D chemistry laboratory is required.
Strong knowledge of analytical chemistry techniques is required.
Must possess effective oral and written communication skills and demonstrate the ability to function effectively in a cross‑functional team environment.
The successful candidate must be self‑driven, have strong critical‑thinking and problem‑solving skills, and be capable of working independently or in a team.

Nice To Haves

Knowledge of sterilization, disinfection, and cleaning technologies for reprocessing medical devices is preferred.
Knowledge and experience in formulation chemistry and design of experiments (DOE) is preferred.
Knowledge and experience in analytical method development, validation, and transfer is preferred.
Professional experience in a GxP‑regulated industry and understanding of ICH, QSR, FDA, and ISO guidelines is preferred.
Experience in validating or qualifying instruments in a GxP‑regulated industry is preferred.
Experience working with detergents, sterilants, and disinfectants is preferred.

Responsibilities

Plans and executes experiments and project tasks in support of new technologies associated with cleaning, disinfection, or sterilization of medical instruments.
Demonstrates research and development techniques; independently determines how to set up and execute experiments and analyses.
Follows prepared protocols and designed experiments to execute research studies under limited supervision to support new product development from feasibility to final product verification/validation.
Performs routine and complex testing in compliance with laboratory test methods and procedures to support timely delivery of tasks related to new product development and product life‑cycle management.
Conducts qualitative and quantitative chemical analysis of raw materials and finished goods.
Develops appropriate protocols, executes studies, organizes data, performs data analysis, and prepares reports.
Supports the 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 action.
Participates in and supports new product development projects through feasibility work to pilot production.
Communicates experiment status and testing results effectively and comprehensively to others.
Supports and coordinates equipment qualifications and maintains laboratory instruments in their qualified state, as well as troubleshoots instrumentation in the event of issues.
Supports OOS, NC, and CAPA investigations for higher‑level scientists as needed.
Provides training to other laboratory personnel in the execution of testing procedures.
Responsible for communicating business‑related issues or opportunities to the next management level.
Provides support to other programs and project teams that require chemistry testing and technical expertise.
Supports teams focused on identifying and implementing process‑level efficiencies.
Responds to questions from ASP customers, government agencies, or auditors according to standard operating procedures.
Supports communication with external suppliers, service providers, and manufacturers.
All employees must comply with applicable laws, regulations, standards, and ASP policies and procedures.