Biocompatibility Engineer/Scientist III
- Katalyst Healthcares and Lifesciences
- New Jersey
- Full Time
- Provide Biocompatibility assessment for Integra's vast majority of products falling into the category of Medical Devices, define applicable Biocompatibility tests to evaluate product compliance to ISO10993 standard, assure product biocompatibility to comply with EUMDR regulations, Work with outside laboratory on Biocompatibility test definitions and arrangements, write final Biocompatibility assessment reports.
- BS or MS degree in Biology/Chemistry or equivalent is preferred.
- Minimum 5 years of experience working in the Medical Device industry is a must
- Knowledge of ISO10993 is a must.
- Experience working with test laboratories for Biocompatibility product assessment.
- Experience working with product development engineering to identify an appropriate representative of product families.
- Excellent writing and communication skills.
- Experience in the scope of Biocompatibility for products for EUMDR compliance.
- Experience in chemical characterization of materials.
- Knowledge of the ISO 10993 series of standards.
- Design a Biocompatibility testing strategy to provide efficient delivery of test results for BSI submissions.
- Provide a Bio comp risk assessment report based on test results.
- Experience with BSI submissions for Biocompatibility.
- Experience working with Class III, Class II, and Class I devices.
Job ID: 487403369
Originally Posted on: 7/30/2025
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