RD Senior Scientist Materials Science and Biocompatibility

Job Category: Research and Development

Position Summary

The Senior Scientist R&D Materials Science and Biocompatibility works under limited supervision and uses knowledge of scientific techniques to execute deliverables pertaining to material compatibility and biocompatibility in support of new product development and lifecycle management projects to achieve ASP business objectives.

Duties and Responsibilities

Under limited supervision and general direction and in accordance with all applicable government laws regulations and ASP policies procedures and guidelines this position:

• Works with crossfunctional teams on sterilization/disinfectant product development.
• Functions as the material science subject matter expert to support all material related testing and evaluation including biocompatibility.
• Designs conducts and interprets experiments to support both capital system and consumable product development evaluation and verification of ASP sterilization and disinfection systems.
• Generates test protocols templates and technical study reports regarding material testing of reprocessing medical devices and provide recommendations to project teams on material selection. Maintains good documentation of all studies.
• Conducts and manages material compatibility and biocompatibility studies for ASP sterilization and disinfection systems and consumable products.
• Works with external labs to form study plans execute the studies and analyze the results. Maintains good documentation practices of all studies.
• Provides progress update and communicate results with upper management and project teams.
• Trains other laboratory personnel in of testing procedures.
• Ensures that projects and experiments are properly designed carefully and diligently conducted properly recorded satisfactorily completed thoroughly summarized and interpretedadherent to GDP and applicable regulations.
• Develops solutions to problems of moderate scope and complexity through the exercise of judgment within defined practices and policies to determine appropriate action.
• Works independently to plan conduct and manage multiple research projects to meet department and company objectives.
• Seeks out new ideas and applications through journals patents scientific reviews and technical meetings.
• Communicates business related issues or opportunities to next management level.
• Performs other duties assigned as needed.

Other Duties:

• Provides technical support to other programs and project teams requiring material science and biocompatibility expertise.
• Leads technicians in support of R&D activities; provides guidance to other scientists as needed.
• Maintains awareness of the advances and needs in material compatibility and biocompatibility including applicable standards and guidelines
• Ensures adherence to compliance standards including monitoring and following relevant guidance documents from ISO and FDA and prepares documentation demonstrating compliance.
• Performs External Standard Gap Assessments (ESGA) to evaluate and address compliance with ISO and EN standards.
• Contributes to building extra ordinary team environment.

Education:

Bachelors Degree Masters Degree or Ph.D. in Materials Science Pharmacology Chemistry Microbiology or closely related technical field.

Years of Related Experience:

Minimum experience and education for this position is a Bachelors degree in Materials Science Pharmacology Chemistry Microbiology or closely related technical field and minimum 5 years of applicable experience or a Masters degree and 3 years of applicable experience or a Ph.D. and 02 years of applicable experience including:

• Experience in the Medical Device or other GxPregulated industry.
• Handson experience in laboratory environment material compatibility and/or biocompatibility testing.

Knowledge Skills Abilities Certifications/Licenses and Affiliations:

• Strong understanding of compliance with applicable laboratory and safety procedure is required.
• Knowledge of material characterization and evaluation is required.
• Knowledge of polymeric material characterization is a plus.
• Knowledge and experience of standards and guidelines on biocompatibility evaluation is required.
• Experience in conducting directly or indirectly biocompatibility testing is required.
• Professional experience in a GxPregulated industry and understanding of QSR FDA EUMDR and ISO guidelines is required.
• Must possess effective oral and written communication skills as well as demonstrate the ability to effectively function in a crossfunctional team environment.
• Working experience with sterilants and disinfectants is preferred.
• Demonstrated experience working with medical washerdisinfectors or sterilizers intended for reprocessing of medical devices is preferred.
• Working knowledge of designs and features of medical devices is preferred.
• Understanding of medical device compatibility with high level disinfectants or sterilants is preferred.
• The successful candidate must be selfdriven have strong critical thinking and problemsolving skills and capable of working independently or in a team.

• Works effectively with crossfunctional teams.
• Works effectively with project teams requiring material science and biocompatibility expertise.
• Provides instructions or supervision to lowerlevel scientists and professionals.
• Assists laboratory colleagues in solving complex problems.