Biocompatibility Engineer

1 week ago

Mysore, Karnataka, India Larsen & Toubro (L&T) Full time ₹ 1,80,000 - ₹ 3,00,000 per year

Job Description of Biocompatibility/Toxicological Risk Assessment/Chemical Analyst- Senior Engineer or Tech lead

1. Develop and prepare a biological evaluation plan and report.

2. Perform gap assessments of products by reviewing legacy documentation and evaluating device BOMs to determine the applicability of test data to ISO 10993 standard.

  1. Write biological risk assessments to ensure all the relevant end points mentioned in ISO 10993 are met.

  2. Participate in the analysis of technical issues and in the development of recommendations for project decisions and actions.

  3. Good Knowledge in of EU MDR 2017/745, ISO 13485, and ISO 14971.

  4. Well Exposure in Chemical and material characterization, and extractable and leachable.

Skills:

  1. University Degree or advanced degree

  2. Good Knowledge on ISO 10993, ISO 13485

  3. Experience in preparing biological evaluation plan

  4. Experience in performing gap assessments with respect to applicable regulatory requirements.

  5. Experience in writing biological risk assessments.

  6. Experience in coordination with cross-functional team

  7. Fluent in English language

  8. Able to work independently or in a team under strict timelines.