Sr Engineer II, Biocompatibility

Job Summary:

The Senior Biocompatibility Engineer plays a crucial role in ensuring the safety and efficacy of medical devices and products through the evaluation of biocompatibility. They are responsible for conducting thorough evaluations of materials used in medical devices, ensuring compliance with relevant regulatory standards and guidelines. 

Duties & Responsibilities:

• Coordinate and oversee the execution of biocompatibility testing with internal teams and external laboratories. 
• Conduct thorough assessments in accordance with applicable regulatory standards such as ISO 10993 and FDA guidance documents. 
• Develop Biological Evaluation Protocols (BEP) and Reports (BER) for products with skin contacting as well as breathing gas pathway healthcare applications, per ISO 10993-1. 
• Perform risk assessments related to biocompatibility, identifying potential hazards and mitigating strategies to ensure compliance with regulatory requirements and standards.
• Analyze, interpret, and draw conclusions from extractables, leachables, particulates, and chemical characterization data. 
• Interface with cross-functional teams to support product development, risk management, and regulatory submissions.

Minimum Qualifications:

• Minimum of 5+ years’ experience in biocompatibility assessment within the medical device industry.
• Strong understanding of ISO 10993 series standards and FDA guidance documents for assessing biocompatibility of medical devices and materials. 
• Familiarity with ISO 18562 series standards for the evaluation of breathing gas pathways of medical devices. 
• In-depth knowledge of biocompatibility testing methodologies, including cytotoxicity, sensitization, irritation, and systemic toxicity.
• Excellent communication skills, both written and verbal, with the ability to effectively collaborate across cross-functional teams. 
• Bachelor's, Master’s, or Ph.D. in a relevant scientific field. 
• Ability to work onsite Monday-Friday in Irvine, CA. 

Preferred Qualifications:

• Experience with biocompatibility submissions and responses to regulatory agencies such as the FDA and EU MDR. 
• Experience with testing for Volatile Organic Compounds (VOC).
• Strong background in chemistry and toxicology.

Compensation: The anticipated range for this position is $132,000 to $158,000. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.