Biomedical Engineer II

Job Description :

POSITION DESCRIPTION : 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. Can you please confirm the 3 main responsibilities / day to day activities required for this role? Design and execute biocompatibility assessment plans and reports in accordance with ISO 10993 and regulatory requirements Support product development lifecycle activities, including design changes and post-market surveillance, from a biocompatibility perspective Interface with laboratories to coordinate testing activities, ensure compliance, and resolve any technical issues.

What products (if any) will this role support? All products across CRM.

Requirement : Must Have

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) Nice To Have

Demonstrated problem solving and critical thinking skills

Effective verbal and written communication skills

Technical understanding of the effect processing has on material properties and performance

The ability to work well under pressure Can you please confirm your top 3 skills sets required? Experience in a regulated industry Knowledge of international and domestic regulations associated with biocompatibility Experience with assessing biocompatibility risk per ISO 10993 standards. What is your target years of experience? 5+ years