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The Biocompatibility Engineer II at Fresenius is a pivotal role within the Quality & Regulatory team, specifically focused on the Vertical In-Center. This position involves participating in design projects, evaluating prototypes, and engaging in research and development activities to assess biocompatibility and toxicological risks associated with Fresenius Medical Care products. The Engineer II will break down high-level tasks into smaller, well-defined tasks, ensuring that all aspects of biocompatibility are thoroughly evaluated. This role requires collaboration with cross-functional teams (CFT) and may involve mentoring entry-level Engineer I employees under the guidance of a supervisor. The Engineer II will possess expertise in relevant standards such as ISO/AAMI 10993, FDA Guidance, and ASTM, and will coordinate biocompatibility testing of materials and products in compliance with FDA and international requirements, including EU MDR. This position also entails preparing and executing biocompatibility test plans in partnership with colleagues and stakeholders, overseeing testing at Contract Research Organizations (CROs), and maintaining project documentation according to quality procedures. The Engineer II will also support the design control process and assist in regulatory affairs by preparing necessary documentation for authority-related correspondences. Additionally, the role includes preparing technical presentations related to biocompatibility projects and coordinating toxicological risk assessments with toxicologists.
