Sr. Disinfection/Materials Engineer

Overview

Senior Disinfection/Materials Engineer - Bothell, WA

FUJIFILM Sonosite, Inc. -- If you are looking for work that matters, you’ll find it at FUJIFILM Sonosite.  As the creator of point of care ultrasound, we dedicate every day to the innovation and development of imaging solutions that enable clinicians to provide improved healthcare in leading institutions, underserved populations and communities in crisis around the globe.  At FUJIFILM Sonosite, we are in the relentless pursuit of answers that allow our customers to be confident that they are making the best clinical decisions for any patient, anywhere, anytime.  Members of the FUJIFILM Sonosite team embody our company values: Go boldly, Stay curious, Passion fuels us, Respect each other, Own it and Act with integrity. Headquartered in Bothell, WA USA, FUJIFILM Sonosite is the proud recipient of numerous prestigious design awards and has in excess of 145 patents.  Our point of care ultrasound systems are sold in more than 100 countries.

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Summary:

The Senior Disinfection/Materials Engineer is responsible for ensuring that Fujifilm Sonosite medical devices and accessories are designed to be cleaned and disinfected by customers in the field. The Senior Disinfection/Materials Engineer operates within the Systems Engineering team and interfaces with specialists within the Hardware Verification, Mechanical Engineering, Product Management, and Clinical Engineering teams. This role will combine biology, chemistry, materials science, clinical workflows, and industry standards to develop well-established safe and effective disinfection procedures for medical ultrasound devices. The Senior Disinfection/Materials Engineer will also provide guidance and leadership in the realm of sustainability, ensuring that FUJIFILM products are designed with materials and processes that have minimal impact on the environment.

Essential Job Functions:

• Apply understanding of the fundamentals of medical device reprocessing to establish cleaning and disinfection procedures for medical ultrasound machines and patient-contacting accessories.
• Ensure that products and processes comply with applicable industry guidance, standards, and regulations on medical device reprocessing.
• Provide guidance to design teams when selecting patient-contacting materials based on biocompatibility and suitability for cleaning and disinfection.
• Determine testing and/or analysis required, including acceptance criteria, to ensure safety and effectiveness when new materials, processes, or disinfection chemicals are proposed for use.
• Devise and perform material-chemical compatibility testing, including development of test apparatus.
• Review verification and validation evidence to make pass/fail decisions on materials, processes, and chemicals; communicate results to customer-facing tools.
• Develop, execute, and document appropriately discriminating test protocols for the qualification of new cleaners, disinfectants, and materials.
• Participate in any post-market investigations related to biocompatibility, material compatibility, and cleaning/disinfection effectiveness.
• Interface with product users, external disinfection chemical suppliers, automated reprocessor manufacturers, and external laboratories as necessary to accomplish job goals.
• Develop strategies and guidance related to sustainability in materials and processes, as aligned with FUJIFILM company initiatives.

Knowledge and Experience:

• Requires a minimum of 5 years relevant industry experience, preferably in an FDA or other regulated industry.
• An undergraduate degree in an engineering or science discipline (Biology, Biomedical Engineering, Chemistry, Chemical Engineering, Material Science, Mechanical Engineering, or other related discipline); Graduate Degree is a plus.
• Experience designing products and processes per industry standards; exposure to medical device safety standards (IEC 60601-1, etc.) and reprocessing standards and regulations (such as FDA reprocessing guidance, EU MDR, and ISO 17664-1) is highly desired.
• Experience with bio- and material compatibility testing; understanding of ISO 10993 family of biocompatibility standards is a plus.
• Experience developing and executing test protocols and composing test plans and reports.
• Experience designing, performing, and overseeing hardware tests involving external laboratories.
• Knowledge of risk assessment per ISO 14971 and its application to material compatibility and reprocessing effectiveness.
• Exposure to IEC 60601-1-9 (Requirements for environmentally conscious design) and experience in sustainability design programs are