Manager, Biocompatibility Engineering - R&D

Manager Of Biocompatibility Engineering

The Manager of Biocompatibility Engineering works within the R&D department to lead and mentor a team of engineers, scientists, and analysts to perform in vivo and in vitro testing for class II and III medical devices (airway and temperature management, and implanted devices). This person will lead efforts to support the biocompatibility and material compliance needs of the organization in addition to overseeing toxicological risk assessments. The role is expected to align with stakeholders and market trends for the on-going development of test strategies and analytical capabilities. They will formulate and implement long-term functional strategies to ensure the continued support, competencies, and technology for on-market and new product development.

Essential Duties & Responsibilities:

• Direct and manage a team of engineers, scientists, and analysts to support new product development efforts and improvements to on-market devices.
• Oversee toxicologists for performing risk assessments and generating toxicology reports.
• Draft and author biocompatibility documentation (BEP, BER, Risk-Benefit analysis documentation.
• Participate in the design and planning of cleaning and disinfection validation protocols for the reprocessing of medical devices.
• Outline comparative analysis studies for the determination of biological, chemical, and physical equivalence.
• Function as the primary contact between ICU and third-party test houses (CRO), ensuring the accuracy and completeness of biocompatibility and chemistry testing.
• Serve as the primary liaison between ICU clinical teams and external consulting firms, translating experimental, clinical, and risk assessment needs into technical requirements and overseeing scope, timelines, and deliverables.
• Review and prepare reports for global regulatory submissions.
• Develop and execute strategic plans to maintain and improve internal and external analytical testing capability for meeting future regulatory and business needs.
• Actively participate in and review industry trends (via standards organizations, technical conferences, and focused review forums).
• Build and maintain strong relations with universities, outside contract research organizations, toxicologists, and consultants to conduct specialized testing and analysis as needed.
• Interact with senior management and others concerning matters of significance to the company and conduct technical briefings as needed.
• Write, review, and issue risk assessments, technical reports, peer reviewed publications, and similar documents for internal and external distribution.
• Create and foster an engaged and motivated working environment in the department through mentoring and coaching.
• Drive product innovation and process improvement within the department.
• Ensure compliance with ICU Medical quality policies and procedures.

Knowledge, Skills & Qualifications:

• Extensive knowledge and experience in biocompatibility assessment, testing, and risk evaluation for class II and III medical devices.
• Excellent documentation, communication, and interpersonal relationship skills including negotiation and relationship management with ability to drive achievement of objectives.
• Deep working knowledge within ISO 10993-1 and related standards.
• Working knowledge of ISO 18562
• Understanding of medical device reprocessing standards (ISO 17664:2017, AAMI ST98).
• Excellent understanding of global regulatory requirements related to medical devices biocompatibility and toxicology.
• Demonstrated capability of managing, leading, and developing direct reports.
• Experience with sample preparation, extract