Position Overview

Perform biocompatibility evaluations to ensure product safety and to support new product development and existing product improvement. Provide biocompatibility support for global regulatory submissions. Job duties:
  • Interface with engineers and project teams to establish biological safety evaluation and testing strategy, sample quantity requirements, and project timelines in compliance with the requirements of ISO 10993 standards and the requirements of the FDA and other regulatory agencies.
  • Provide guidance and support in the development of new products and the selection of materials to ensure that released designs meet biological safety requirements.
  • Prepare documentation for biological assessments including biocompatibility evaluation protocols and reports. Coordinate biological testing activities by partnering with approved external laboratories to meet project timelines.
  • Assess the biological safety impact from manufacturing and supplier changes on existing patient-contacting devices.
  • Provide biocompatibility support for regulatory submissions.
  • Play a role in establishing and improving the biological evaluation program as part of risk management processes in a manner that complies with ISO 10993.
  • Perform biocompatibility assessment activities in compliance with the Quality System.
  • Perform additional duties as assigned.

    1. Bachelor of Science degree in a related field.
    2. Minimum of one (1) year of experience in the medical device or pharmaceutical industry performing or overseeing biological safety assessments and related risk assessments, or equivalent experience.
    3. Working knowledge of ISO 10993 standards for biocompatibility and understanding of principles and techniques of biocompatibility assessment.
    4. Computer proficiency including MS Word, Excel, PowerPoint, and Outlook.
    5. Strong verbal and written communication skills.
    6. Willingness to learn and advance knowledge.
    7. Ability to work in a cross-functional environment while building positive internal/external working relationship.
    Desired Qualifications
    1. Advanced degree (MS or PhD) in a related field.
    2. Knowledge in chemical analysis and toxicological risk assessment, molecular cell biology, materials science, and global regulatory requirements for biocompatibility evaluation of class II and III medical devices.
    3. Knowledge of applicable ASTM, ISO, FDA, and other standards.
    4. Understand the concepts of patient safety and quality control.