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.