Senior Biocompatibility Engineer - ISO 10993 Expert

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

Job summary

Planet Pharma is seeking a Biocompatibility Specialist to evaluate the safety and compatibility of medical devices with biological systems. You will plan and execute ISO 10993 testing, analyze data, and prepare regulatory submissions while supporting product development and post-market activities.

The role requires a University Degree and 4+ years of relevant experience, or an advanced degree with 2+ years.

Qualifications

• Experience in regulated industry and knowledge of biocompatibility regulations.
• Experience with assessing biocompatibility risk per ISO 10993 standards.
• 5+ years of relevant experience.

Responsibilities

• Design and place biocompatibility testing per ISO 10993 and regulatory guidelines.
• Collaborate with cross-functional teams to support product development and post-market activities from a biocompatibility perspective.
• Coordinate testing with laboratories to ensure compliance and resolve technical issues.
• Review test results and document findings for regulatory submissions.
• Stay current with evolving biocompatibility standards and regulatory expectations.

Skills

Regulated industry experience

ISO 10993 knowledge

Biocompatibility risk assessment

Education

University Degree

Advanced degree

Job description

Planet Pharma is seeking a Biocompatibility Specialist to evaluate the safety and compatibility of medical devices with biological systems. You will plan and execute ISO 10993 testing, analyze data, and prepare regulatory submissions while supporting product development and post-market activities.

The role requires a University Degree and 4+ years of relevant experience, or an advanced degree with 2+ years.