Biocompatibility Engineer

About the role

Primary Talent Partners has a new contract opening for a Sr Biomedical Engineer with our medical device client in Mounds View, MN. This is a 23-month contract with a potential for extension. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.

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.

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.
• Design, develop and provide safety testing, repair, and maintenance of biomedical equipment.
• Ensure that 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.

Skills

• 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.

Pay

$60.00 - $70.00/hr; W2 contract, no PTO, no Benefits. ACA-compliant supplemental package available for enrollment.

Schedule

23-month contract with potential for extension.

Benefits

No traditional benefits provided; ACA-compliant supplemental package available for enrollment.