Biocompatibility Engineer
Actively Reviewing the ApplicationsCyient
Mumbai
Full-Time
4–8 years
Posted 2 days ago
•
Apply by June 11, 2026
Job Description
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.
- 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.
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