Biocompatibility Expert (Engineer / Senior Engineer /

Location

Pune, Maharashtra, India

Salary

Not specified

Company

Akash pawar

Job description

### Role & Company / Project Overview Tata Elxsi is hiring Biocompatibility experts at multiple levels including Engineers, Senior Engineers, and Specialists to join our medical devices engineering team in Pune. If you have hands-on experience with Medical Devices, EU MDR, ISO 10993, biological evaluation, and material compliance, this role offers an exciting career opportunity. ### Key Responsibilities & Daily Duties - Define and execute biological evaluation strategies per ISO 10993 and EU MDR. - Review material composition, supplier data, and existing biocompatibility evidence. - Conduct impact assessment due to lifecycle changes in medical devices. - Prepare and update BEPs, BERs, and Biological Risk Assessments (BRAs). - Perform gap assessments and recommend testing or justification approaches. - Collaborate with Toxicology and Risk Management teams for integrated assessments. - Support responses to Notified Body queries related to biocompatibility and material safety. ### Required Qualifications, Skills & Experience - Relevant experience in Biocompatibility evaluation for Medical Devices. - Hands-on expertise with EU MDR and ISO 10993 standards. - Deep understanding of biological evaluation, material compliance, and safety documentation. - Strong background in BEP/BER creation, risk assessments, and Notified Body query handling. ### Working Hours, Shifts & Location Details - Work Location: Pune, Maharashtra, India. ### Application Instructions - Send your resume or referrals directly to the recruitment email.