Biocompatibility Engineer

Roles & Responsibilities

• Develop and execute biocompatibility evaluation plans and reports.
• Assess material composition, manufacturing processes, and potential biological risks.
• Coordinate testing with external laboratories and review study protocols/reports.
• Support risk assessments and justification for biological safety.
• Ensure compliance with ISO 10993 series, FDA, and EU MDR requirements.
• Collaborate with R&D, Regulatory, and Quality teams for product development and change control.
• Maintain documentation and support regulatory submissions.

Qualifications

• Bachelor's/Master's in Biomedical, Materials, or Chemical Engineering, or related field.
• 5+ years' experience in biocompatibility or toxicology within the medical device industry.
• Strong knowledge of ISO 10993, ISO 14971, and FDA biocompatibility guidance.
• Experience reviewing test reports and preparing biological evaluation reports (BERs).
• Excellent analytical, documentation, and cross-functional communication skills.