Biocompatibility Engineer

We are looking for

• A bachelor's 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 in 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.
• Knowledge of Product Lifecycle Management.
• Prior experience independently developing biological safety assessments for inclusion with regulatory submissions is preferred.
• Knowledge of standards for biocompatibility of breathing gas pathways in healthcare applications, e.g. ISO 18562, is preferred.
• Industry experience in medical device materials and product development is preferred.
• Experience in supporting regulatory submissions, namely 510ks, is preferred.
• Experience working with internal and external scientific standard organizations (e.g. ISO/TC 194) is preferred.
• 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 the 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 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.