Job Title Evaluating medical device products for safety per internal procedures, US and international regulations, and the ISO 10993 Standard series. Assisting in the design and implementation of biocompatibility testing systems and procedures for Ethicon and across the Johnson & Johnson Medical Device sector. Ensuring appropriate documentation is established and maintained to support that the biocompatibility and toxicity testing meet all US and international test requirements per ISO, FDA (US Food and Drug Administration), and GLPs (good laboratory practices).Coordinating, designing, implementing, and analyzing testing systems, procedures, and test results for biocompatibility/toxicology evaluations and in vivo / in vitro studies. Reviewing, interpreting, and summarizing toxicological and material chemistry raw data from reports. Applying technical expertise to solve complex biocompatibility problems, utilizing ingenuity and business experience. Serving as the sponsor for applicable GLP / non-GLP biocompatibility studies per current global regulatory and compliance requirements. Very strong in medical-grade Materials identification and release process. Strong in Medical device standards. Top Skills: Biocompatibility Testing Knowledge Validating Toxicologist reports Medical-grade materials
Additional Details: B.E. Mechanical, Biotechnology, or Equivalent
