Senior Biomedical Engineer

Redbock - an NES Fircroft company; Mounds View (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Redbock - an NES Fircroft company in Minnesota seeks a Senior Biomedical Engineer for a 24-month contract in Mounds View. You will lead biocompatibility assessments and ensure regulatory compliance.

You will collaborate with cross-functional teams to plan testing, review ISO 10993 data, and support post-market activities while staying current with global standards.

Qualifications

• Bachelor’s Degree in Materials Science and Engineering or related field.
• 5+ years of experience with biocompatibility testing and compliance.
• Experience with ISO 10993 biocompatibility testing and regulatory requirements.

Responsibilities

• Design and execute biocompatibility assessment plans and reports per ISO 10993 and regs.
• Coordinate testing with laboratories, ensure compliance, resolve technical issues.
• Review and interpret lab results; document findings in regulatory submissions.
• Support product development and post-market activities from a biocompatibility view.
• Stay current with global biocompatibility standards and regulatory expectations.

Skills

Regulated industry experience

ISO 10993 biocompatibility knowledge

Biocompatibility risk assessment

Education

Bachelor’s Degree in Materials Science and Engineering

Job description

Sr. Biomedical Engineer (24-month contract // Mounds View, MN)

Top 3 Skills Required:

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

Primary Responsibilities:

• 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.

Education:

Requires a Bachelor’s Degree, ideally in Materials Science and Engineering or related scientific/engineering disciplines

Target Years of Experience:

5+ years of experience with biocompatibility testing and compliance

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.

Duties:

• 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.