Scientist I
Fortive
Location: Irvine, CAThe Scientist I will use knowledge of scientific techniques to contribute to validation or qualification of external devices to be reprocessed in company products and designing and developing safe and effective company products in compliance to new product development procedures.Responsibilities:Under supervision and general direction and in accordance with all applicable government laws, regulations and ASP policies, procedures and guidelines, this position:Performs various routine laboratory studies and assignments to support the validation and qualification of medical devices for reprocessing in ASP sterilization and disinfection systems within the ASP Technical Business Solutions Team (TBS) and other ASP functions.Supports, or leads if needed, drafting of technical documents such as protocols, test reports, and technical reports using templates and examples from previous studies and communicate results to stakeholders, as needed.Expected to contribute to the organization and directions of experiments and perform experiments under supervision to evaluate the development and assessment of new technologies for potential products following the regulatory guidelines / standards (FDA, TGA, ISO etc.).Ensures that projects and experiments are carefully and diligently conducted, properly recorded, satisfactorily completed, and thoroughly summarized.Follows prepared protocols and designed experiments to execute research studies under supervision to support product development from feasibility to final product verification / validationExpected to demonstrate research and development techniques.Supports 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 actions.Effectively communicates experiment status / testing results to others.Requires a limited to full use of application of basic to standard principles, theories, concepts, and techniquesSupports laboratory equipment validation programSupports OOS, CAPA, laboratory investigations, and other investigatory processes led by higher level scientists as needed.Must be able to provide training to other laboratory personnel in execution of testing proceduresResponsible for communicating business related issues or opportunities to next management level.Performs other duties assigned as neededOther Duties:Provide support to other programs and project teams that require testingSupport team focused on identifying and implementing process level efficienciesSupport in maintaining awareness of the advances and needs in sterilization / disinfection, microbiology and biocompatibilityContribute to building extra ordinary team environmentQualificationsEducation:Bachelor's Degree in a scientific discipline. such as Microbiology, Biology, or a closely related field.Years of Related Experience:0-2 years in laboratory or related environmentKnowledge, Skills, Abilities, Certifications/Licenses, and Affiliations:(Include any required computer skills, regulatory knowledge, certifications, licenses, languages, cognitive and behavioral abilities etc.)Strong understanding of compliance with applicable laboratory and safety procedure is requiredKnowledge of sterilization, disinfection and cleaning technologies for reprocessing of medical devices is strongly preferredProfessional experience in a GxP-regulated industry and understanding of QSR, FDA, and ISO guidelines is preferredThe successful candidate must be self-driven, have strong critical thinking and problem-solving skills, and capable of working independently or in a team.Must possess effective oral and written communication skills as well as demonstrate the ability to effectively function in a cross-functional team environmentWorking experience with sterilants and disinfectants is preferredWorking experience with medical washer-disinfectors or sterilizers intended for reprocessing of medical devices is preferredExperience in validation or qualifying medical devices for reprocessing in medical washer-disinfectors or sterilizers is preferredWorking knowledge of designs and features of medical devices is preferredFortive Corporation OverviewFortive's essential technology makes the world safer and more productive. We accelerate transformation in high-impact fields like workplace safety, build environments, and healthcare.We are a global industrial technology innovator with a startup spirit. Our forward-looking companies lead the way in healthcare sterilization, industrial safety, predictive maintenance, and other mission-critical solutions. 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 advanced technologies that help providers focus on exceptional patient care.We are a diverse team 10,000 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.At Fortive, we believe in growth. We're honest about what's working and what isn't, and we never stop improving and innovating.Fortive: For you, for us, for growth.About Advanced Sterilization Products ASP is a leading global provider of innovative sterilization and disinfection solutions, and a pioneer of low-temperature hydrogen peroxide sterilization technology.ASP’s mission is to protect patients during their most critical moments. We support healthcare facilities in the fight to protect patients against hospital acquired infections, which are a leading cause of morbidity and mortality. ASP’s products, which are sold globally, include the STERRAD system for sterilizing instruments and the EVOTECH and ENDOCLENS systems for endoscope reprocessing and cleaning. 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 View email address on click.appcast.io. Bonus or EquityThis position is also eligible for bonus as part of the total compensation package.Pay RangeThe salary range for this position (in local currency) is 65,090 - 108,675Department:Science
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