Biocompatibility Scientist III

Job Description

Duties and Responsibilities:

• Provide Biocompatibility assessment for Client’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.

Education and Experience:

• BS or MS degree in Biology/Chemistry or equivalent is preferred,
  Min 5-year experience working in Medical Device industry is a must.
• Experience working with test laboratories for Biocompatibility product assessment.
• Experience working with product development engineering to identify appropriate representative of product families.
• Experience with BSI submissions for Biocompatibility.
• Experience working with Class III, class II and class I devices
• Experience in the Product of Biocompatibility for products for EUMDR compliance.
• Experience in chemical characterization of materials.

Knowledge, Skills and Abilities:

• Excellent writing and communication skills.
• Knowledge of ISO10993 is a must.
• Knowledge of ISO 10993 series of standards.
• Design Biocompatibility testing strategy to provide efficient delivery of test results for BSI submissions.
• Provide Bio comp risk assessment report based on test results.