ICU Medical · 2 hours ago
Manager, Biocompatibility Engineering - R&D
United States
Full-time
Onsite
Senior Level
7+ years expICU Medical is a global market leader in IV therapy and critical care products. The Manager of Biocompatibility Engineering will lead a team to perform testing for medical devices and ensure compliance with biocompatibility and material standards while overseeing toxicological risk assessments.
Health CareMedical Device
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
Qualification
Required
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, extraction, and separation techniques for polymer material analyses, analytical chemistry, and instrumentation analysis - e.g. FTIR, HPLC, GC, IC, ICP-MS, GC/MS techniques
Experience reading, analyzing, and interpreting common scientific and technical journals/literature, scientific procedures and regulatory guidelines, and writing technical reports, toxicological risk assessments, and biocompatibility evaluations
Able to work quickly and effectively in a fast-paced, dynamic work environment
Proficient in the use Microsoft Office tools - Word, Office, Power Point, and Outlook
Bachelor's degree in Science or Engineering (Chemistry or Materials/Polymers) from an accredited college or university; MS or PhD is preferred
Minimum 7-15 years of relevant experience in the medical device industry or combination of medical device and pharmaceutical/biotechnology
Company
ICU Medical
ICU Medical connects patients and caregivers through safe, life-saving, life-enhancing IV therapy systems, software, solutions, and consumables.
Founded in 2019San Clemente, California, USA
5001-10000 employees
H1B Sponsorship
ICU Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (24)
2024 (14)
2023 (27)
2022 (31)
2021 (12)
2020 (14)
Funding
Current Stage
Late StageTotal Funding
$1.3M2012-08-15Undisclosed· $1.3M
Leadership Team
Allison Knight
Human Resources Business Partner
Ben Sousa
Chief Information Officer
Company data provided by crunchbase