Senior Biocompatibility Engineer - Independent R&D Lead

Lancesoft; Mounds View (MN); On-site; USD 90,000 - 130,000; Full time

Job summary

Lancesoft in Mounds View, MN is seeking a seasoned biocompatibility specialist responsible for evaluating the safety and compatibility of medical devices with biological systems. This role offers a collaborative environment and opportunities for professional growth.

You will design and execute ISO 10993-based assessment plans, coordinate with laboratories, review results, and support regulatory submissions and post-market activities.

Qualifications

• Minimum 4 years relevant experience with a Bachelor’s degree, or Master’s with 2+ years, or PhD with 0 years.
• Solid knowledge of ISO 10993 and regulatory requirements.
• Experience reviewing lab results and preparing regulatory submissions.
• Ability to design and execute biocompatibility assessment plans.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Design and execute biocompatibility assessment plans and reports per ISO 10993 and regulatory requirements.
• Coordinate testing activities with laboratories to ensure compliance and resolve issues.
• Review and interpret laboratory results; document findings for reports and submissions.
• Support product development lifecycle from a biocompatibility perspective.
• Stay current with global biocompatibility standards and regulatory expectations.

Skills

Biocompatibility

Regulatory awareness

Independent worker

Project leadership

Cross-functional collaboration

Education

Bachelor’s degree + 4+ years

Master’s degree + 2+ years

PhD + 0 years

Job description

Lancesoft in Mounds View, MN is seeking a seasoned biocompatibility specialist responsible for evaluating the safety and compatibility of medical devices with biological systems. This role offers a collaborative environment and opportunities for professional growth.

You will design and execute ISO 10993-based assessment plans, coordinate with laboratories, review results, and support regulatory submissions and post-market activities.