R&D Scientist II, Material Compatibility

Fortive•Irvine, CA

17d

About The Position

The R&D Scientist II, Material Compatibility works under moderate supervision and applies materials science principles to support material compatibility testing, analysis, and documentation for ASP sterilization and disinfection systems and consumable products. This role contributes to new product development and product lifecycle management by executing studies, organizing data, and preparing technical reports in accordance with applicable procedures and regulations. Duties and Responsibilities 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 related to material compatibility for capital equipment and consumables used in the reprocessing of medical devices. Follows approved protocols, templates, and test methods; conducts studies, organizes data, performs data analysis, and prepares technical reports using good documentation practices (GDP). Conducts material evaluations such as polymer/component assessments, surface and appearance checks, and functional evaluations, and summarizes findings. Conducts qualitative and quantitative chemical analysis. Conducts and manages material compatibility studies for ASP sterilization and disinfection systems and consumable products. Supports material selection activities by gathering information from literature, vendors, and internal resources, and performing comparative screening studies. Coordinates samples and testing with external laboratories, including test setup details, logistics, and timeline tracking; reviews laboratory reports and incorporates results into study summaries and reports. Maintains laboratory instruments in a qualified state; performs routine checks and troubleshooting, escalating issues as needed. Supports verification and validation activities related to material compatibility. Ensures experiments are properly conducted, documented, and summarized in compliance with GDP and relevant regulations. Communicates study status and results clearly to project teams and management. Provides training to technicians or peers on routine procedures and test methods as assigned. Supports NC and CAPA investigations within the scope of material compatibility testing. Communicates business-related issues or opportunities to the next management level. Performs other duties as assigned. Other Duties Provides technical support to other programs and project teams requiring material compatibility input. Supports process improvements, including updates to templates, methods, and documentation practices. Contributes to maintaining a strong team environment. Assists in maintaining awareness of relevant standards and guidelines (e.g., ISO, FDA) and supports documentation for compliance audits.

Requirements

Bachelor’s or Master’s degree in Materials Science or Chemistry or a closely related field.
A Bachelor’s degree in Materials Science, Chemistry or a closely related field with more than 3 years of applicable experience, or a Master’s degree in Materials Science, Chemistry or a closely related field with 1–3 years of applicable experience
Experience in the medical device or other GxP-regulated industry.
Hands-on experience in a laboratory environment and material compatibility.
Strong understanding of laboratory safety, compliance, and good documentation practices is required.
Knowledge of material characterization and evaluation is required; experience with polymeric materials is a plus.
Familiarity with standards and guidelines related to material compatibility evaluation is required.
Excellent written and verbal communication skills are essential, along with the capability to collaborate successfully within cross-functional teams.
Ability to think critically, solve problems, and work independently or as part of a team is required.

Nice To Haves

Knowledge and experience in analytical chemistry and design of experiments (DOE) is preferred.
Experience working with sterilants, disinfectants, or medical device reprocessing technologies is preferred.

Responsibilities

Plans and executes experiments and project tasks related to material compatibility for capital equipment and consumables used in the reprocessing of medical devices.
Follows approved protocols, templates, and test methods; conducts studies, organizes data, performs data analysis, and prepares technical reports using good documentation practices (GDP).
Conducts material evaluations such as polymer/component assessments, surface and appearance checks, and functional evaluations, and summarizes findings.
Conducts qualitative and quantitative chemical analysis.
Conducts and manages material compatibility studies for ASP sterilization and disinfection systems and consumable products.
Supports material selection activities by gathering information from literature, vendors, and internal resources, and performing comparative screening studies.
Coordinates samples and testing with external laboratories, including test setup details, logistics, and timeline tracking; reviews laboratory reports and incorporates results into study summaries and reports.
Maintains laboratory instruments in a qualified state; performs routine checks and troubleshooting, escalating issues as needed.
Supports verification and validation activities related to material compatibility.
Ensures experiments are properly conducted, documented, and summarized in compliance with GDP and relevant regulations.
Communicates study status and results clearly to project teams and management.
Provides training to technicians or peers on routine procedures and test methods as assigned.
Supports NC and CAPA investigations within the scope of material compatibility testing.
Communicates business-related issues or opportunities to the next management level.
Performs other duties as assigned.
Provides technical support to other programs and project teams requiring material compatibility input.
Supports process improvements, including updates to templates, methods, and documentation practices.
Contributes to maintaining a strong team environment.
Assists in maintaining awareness of relevant standards and guidelines (e.g., ISO, FDA) and supports documentation for compliance audits.