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Biocompatibility Associate, Medical Devices, MDR

Company: GForce Life Sciences
Location: Westminster
Posted on: November 26, 2022

Job Description:

SummaryGForce Life Sciences has been engaged by a growing medical device company to identify a Biocompatibility Associate who will make an important contribution to patient safety by supporting projects/programs in terms of biocompatibility of medical devices, materials, and processes. This role will work closely with program/project cross-functional teams to provide biocompatibility deliverables in compliance with global regulatory requirements such as ISO 10993.
Duties / Expectations of Role Material Documentation Support and Testing

  • Compile data from testing or other evaluation/approval documentation
  • Populate document templates, and review and fill out portions of the Biocompatibility
  • Evaluation risk assessment (data tables, names, results, parameters, etc.)
  • Review memos for biocompatibility strategies, material approvals, and device approvals
  • Review device Bill of Materials, engineering drawings, and supplier documentation for accuracy and transcription to new documents, for material and manufacturing process information, and for identification of potential biocompatibility impact
  • Assist engineers in the preparation of biocompatibility samples to be sent for testing by providing guidance on sample collection, handling, packaging, and inspection
  • Coordinate testing of biocompatibility samples with contract laboratories, determine sample requirements and review and provide feedback on engineering studies
  • Verify accuracy of test-sample information on analytical test reports and the presentation of the data. Verify risk assessment calculations (basic math) for Toxicologists
  • Maintain and track biocompatibility test samples through progression of testing
    Data Searching
    • Maintenance and data entry in Biocompatibility Database
    • Research material- and biocompatibility-related questions, including database searches Mandatory Requirements
      • Bachelor's degree in Biology or Science is preferred
      • 1-3 years of experience in medical device, biotechnology, pharmaceutical field, or academia
      • Familiarity with ISO 10993 and EU MDR
      • Must possess solid collaboration skills and be able to work in a team environment
      • Work independently with some supervision and have initiative to drive projects forward
      • Able to work on a variety of projects and shift priorities as needed
      • Able to prioritize, organize, and plan with adherence to deadlines, and communicate any deadline obstacles in a timely manner
      • Attention to detail and organization of data with high degree of confidentiality
      • Able to follow procedures with accuracy and precision, including a sequence of tasks
      • Computer skills required - Windows, MS Office (with an emphasis on Excel and Word) Nice to Have
        • Fundamental understanding or direct experience of the ISO 10993 standards, biomaterials, toxicological assessment, extractable and leachable analysis, medical device manufacturing processes, and biocompatibility assessment methodology
          Term & Start
          • Start immediately
          • Benefits available
          • Hybrid - Onsite 1-2 days a week in CO
          • Contract to hire

Keywords: GForce Life Sciences, Denver , Biocompatibility Associate, Medical Devices, MDR, Healthcare , Westminster, Colorado

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