Senior Biomedical Engineer

ATR International; Minneapolis (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

ATR International is seeking a Biocompatibility Specialist to evaluate safety and compatibility of medical devices with biological systems. You will plan and place biocompatibility testing per ISO 10993 standards, collaborate with cross-functional teams, analyze data, and support regulatory submissions.

You will stay current with evolving global standards and contribute to strategies for new products and post-market activities from a biocompatibility perspective.

Qualifications

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

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 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.

Skills

Regulatory experience

Biocompatibility knowledge

ISO 10993 risk assessment

Education

University degree

Advanced degree

Job 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.

REQUIREMENTS:

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

Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.