Biocompatibility Engineer
- Employer
- Katalyst Healthcares & Life Sciences
- Location
- Trumbull, CT
- Closing date
- Jan 26, 2023
View more
- Sector
- Science, Physical Sciences and Engineering
- Organization Type
- Corporate
You need to sign in or create an account to save a job.
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
You need to sign in or create an account to save a job.
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert