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Biocompatibility Engineer

Katalyst Healthcares & Life Sciences
Trumbull, CT
Closing date
Jan 26, 2023

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Job Description Responsibilities:
  • Strong cooperation with cross functional teams
  • Deliver biocompatibility assessments and biocompatibility evaluation plans and reports complying with applicable biological evaluation standards and FDA/ISO guidance documents within a risk-based framework
  • Collaborate with a cross-functional team to support multiple projects requiring biocompatibility evaluation ensuring timely completion of required tasks to meet project schedules
  • Analyse biocompatibility test results to determine adequacy of data to meet requirements for the biological effects and utilize problem solving skills and technical knowledge to troubleshoot unexpected results
  • Assist with regulatory submissions to global regulatory agencies in order to elaborate on the ResMed product biocompatibility strategy and data in response to additional information requests
  • Participate in design and risk review meetings to address device biological safety concerns and ensure the proper records of biological safety assessments and test plans/reports
  • Learn and maintain a working knowledge of applicable external standards and industry requirements for the biological safety of medical devices
  • Perform and assist gap analysis of external standards, regulatory requirements and guidance associated with biological safety evaluation, and minimize the negative impact of such gaps on ResMed products and business
  • Identify part information and perform analysis for biocompatibility evaluation assessments - Comply to process requirements and meet standards.
  • A bachelor or master's degree with a discipline in Toxicology, Chemistry, Biochemistry, Biomedical Engineering, or equivalent
  • 4-8 years of industrial/technical work experience in an FDA/ISO regulated environment performing biological safety evaluations
  • Experience of applying the principles, theories, and concepts in biocompatibility per ISO 10993/18562 - Understanding of FDA and ISO 10993 biological safety requirements and/or test methods
  • Working knowledge of Good Laboratory and Good Manufacturing practices (GLP and GMP). - Experience in Cleaning, Sterilization and Biocompatibility in a medical device setting.
  • Liaising with contractors and external suppliers.
  • Experience with auditing and reporting procedures
  • Understanding of Healthcare/Medical Devices domain related compliance standards and regulations
: 22-01708 : Trumbull, CT:
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