Biocompatibility Engineer

• The individual in this position is responsible for evaluating the safety and compatibility of medical devices with biological systems. 
• The 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. 

• Experience in a regulated industry.
• Knowledge of international and domestic regulations associated with biocompatibility. 
• Experience with assessing biocompatibility risk per ISO 10993 standards.

Qualifications:

• Requires a University Degree and 5+ years of experience