Irvine, CA, 92604, USA
1 day ago
R&D 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 cross-functional 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 execution of testing procedures. + Ensures that projects and experiments are properly designed, carefully and diligently conducted, properly recorded, satisfactorily completed, thoroughly summarized and interpreted, adherent 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. **Qualifications** **Education:** Bachelor’s Degree, Master’s 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 Bachelor’s degree in Materials Science, Pharmacology, Chemistry, Microbiology, or closely related technical field and minimum 5+ years of applicable experience, or a Master’s degree and 3+ years of applicable experience, or a Ph.D. and 0-2 years of applicable experience, including: + Experience in the Medical Device or other GxP-regulated industry. + Hands-on 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 GxP-regulated 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 cross-functional team environment. + Working experience with sterilants and disinfectants is preferred. + Demonstrated experience working with medical washer-disinfectors 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 self-driven, have strong critical thinking and problem-solving skills, and capable of working independently or in a team. **Responsibility for Others and Internal Interactions** + Works effectively with cross-functional teams. + Works effectively with project teams requiring material science and biocompatibility expertise. + Provides instructions or supervision to lower-level scientists and professionals. + Assists laboratory colleagues in solving complex problems. **Physical & Work Environment Requirements** **Physical Requirements:** The physical demands identified are representative of the physical requirements necessary for an employee to successfully perform the essential functions of this job. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions of this job. While performing the responsibilities of this job, the employee may be required to talk and hear. **Work Environment** **Travel on the Job:** 10-20% **☒ Domestic ☒ International** **☒Scheduled Work Hours** **☐Shift Work** **☐On Call (Call in for Work)** **Approximate Position Requirements** **Standing:** Up to 50% **Kneeling:** 0-10% **Sitting:** Up to 50% **Walking:** Up to 50% **Additional Work Environment Requirements** **☒N/A** None **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. Fortive: For you, for us, for growth. This position is also eligible for bonus as part of the total compensation package. The salary range for this position (in local currency) is 100,700.00 - 186,900.00 We are an Equal Opportunity Employer Fortive Corporation and all Fortive Companies are proud to be equal opportunity employers. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity or expression, or other characteristics protected by law. Fortive and all Fortive Companies are also committed to providing reasonable accommodations for applicants with disabilities. Individuals who need a reasonable accommodation because of a disability for any part of the employment application process, please contact us at applyassistance@fortive.com.
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