Job Description

The Biomedical Engineer II is responsible for evaluating the safety and compatibility of medical devices with biological systems. This role involves planning and placing biocompatibility testing in accordance with ISO 10993 standards, regulatory guidelines, and risk assessment principles. This individual collaborates with cross-functional teams to ensure materials meet safety requirements. This individual analyzes data, prepares technical reports, and supports regulatory submissions. This position may also be involved in developing strategies for new products and addressing biocompatibility related issues during product development and post-market activities.

POSITION RESPONSIBILITIES:

Design and execute biocompatibility assessment plans and reports in accordance with ISO 10993 and regulatory requirements. Interface with laboratories to coordinate testing activities, ensure compliance, and resolve any technical issues. Review and interpret laboratory test results; document findings in technical reports and regulatory submissions. Support product development lifecycle activities, including design changes and post-market surveillance, from a biocompatibility perspective. Stay current with evolving global biocompatibility standards, guidance documents, and regulatory expectations to ensure ongoing compliance. Designs, develops and provides safety testing, repair, and maintenance of biomedical equipment. Ensures that the biomedical equipment is in compliance with applicable regulatory requirements and quality control standards. Design studies and conduct research on enzyme reactions and the effects of organic compounds on biological processes. Participate in activities such as compound screening and compound optimization programs, and developing and running enzyme assays. POSITION REQUIREMENTS: Bachelor's degree in materials science, chemical engineering, biocompatibility or a related technical field. Advanced degrees will also be considered. Experience in a regulated industry. Knowledge of international and domestic regulations associated with biocompatibility. Knowledge of materials and interactions with the body and environment. Knowledge of Microsoft applications (Excel, Word, Outlook) Development Resource Group

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