R&D Scientist II, Material Compatibility

Position Summary
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.

Qualifications

Education:
Bachelors or Masters degree in Materials Science or Chemistry or a closely related field.

Years of Related Experience:
A Bachelors degree in Materials Science Chemistry or a closely related field with more than 3 years of applicable experience or a Masters degree in Materials Science Chemistry or a closely related field with 13 years of applicable experience including:
Experience in the medical device or other GxP-regulated industry.
Hands-on experience in a laboratory environment and material compatibility.

Knowledge Skills and Abilities
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.
Knowledge and experience in analytical chemistry and design of experiments (DOE) is preferred.
Excellent written and verbal communication skills are essential along with the capability to collaborate successfully within cross-functional teams.
Experience working with sterilants disinfectants or medical device reprocessing technologies is preferred.
Ability to think critically solve problems and work independently or as part of a team is required.

Responsibility for Others and Internal Interactions
Works effectively with cross-functional project teams requiring material compatibility input.
May provide day-to-day guidance to technicians on routine test execution; no direct supervisory responsibilities.

External Interactions
Collaborates with external laboratories to plan testing execute studies and interpret results under supervision.
Supports communication with external suppliers service providers and manufacturers.
Responds to questions from ASP customers government agencies or auditors according to standard operating procedures.

Travel Requirements
0-10% Domestic.

Compliance
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 jobrelated tasks as assigned by their supervisor. Reasonable accommodations may be made for individuals with disabilities.