Job Description\n\n Position Summary \n \nThe 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. \n \nEssential Duties & Responsibilities\n \n \n * Direct and manage a team of engineers, scientists, and analysts to support new product development efforts and improvements to on-market devices. \n * Oversee toxicologists for performing risk assessments and generating toxicology reports. \n * Draft and author biocompatibility documentation (BEP, BER, Risk-Benefit analysis documentation. \n * Participate in the design and planning of cleaning and disinfection validation protocols for the reprocessing of medical devices. \n * Outline comparative analysis studies for the determination of biological, chemical, and physical equivalence. \n * Function as the primary contact between ICU and third-party test houses (CRO), ensuring the accuracy and completeness of biocompatibility and chemistry testing. \n * 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. \n * Review and prepare reports for global regulatory submissions. \n * Develop and execute strategic plans to maintain and improve internal and external analytical testing capability for meeting future regulatory and business needs. \n * Actively participate in and review industry trends (via standards organizations, technical conferences, and focused review forums). \n * Build and maintain strong relations with universities, outside contract research organizations, toxicologists, and consultants to conduct specialized testing and analysis as needed. \n * Interact with senior management and others concerning matters of significance to the company and conduct technical briefings as needed. \n * Write, review, and issue risk assessments, technical reports, peer reviewed publications, and similar documents for internal and external distribution. \n * Create and foster an engaged and motivated working environment in the department through mentoring and coaching. \n * Drive product innovation and process improvement within the department. \n * Ensure compliance with ICU Medical quality policies and procedures. \n\nKnowledge, Skills & Qualifications\n \n \n * Extensive knowledge and experience in biocompatibility assessment, testing, and risk evaluation for class II and III medical devices. \n * Excellent documentation, communication, and interpersonal relationship skills including negotiation and relationship management with ability to drive achievement of objectives. \n * Deep working knowledge within ISO 10993-1 and related standards. \n * Working knowledge of ISO 18562 \n * Understanding of medical device reprocessing standards (ISO 17664:2017, AAMI ST98). \n * Excellent understanding of global regulatory requirements related to medical devices biocompatibility and toxicology. \n * Demonstrated capability of managing, leading, and developing direct reports. \n * 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. \n * 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. \n * Able to work quickly and effectively in a fast-paced, dynamic work environment. \n * Proficient in the use Microsoft Office tools - Word, Office, Power Point, and Outlook \n\nEducation and Experience \n \n \n * Bachelor's degree in Science or Engineering (Chemistry or Materials/Polymers) from an accredited college or university; MS or PhD is preferred \n * Minimum 7-15 years of relevant experience in the medical device industry or combination of medical device and pharmaceutical/biotechnology \n\nTravel Requirements \n \n \n * Typically requires travel less than 5 % of the time \n\nPhysical Requirements and Work Environment \n \n \n * This is a mix office and laboratory role. \n * This job operates in a professional office environment and routinely uses standard office equipment. \n * Must be able to occasionally move and lift objects of up to 25 lbs \n\nAbout Us\n\nICU Medical has consistently provided you with clinical innovations that help solve real-world challenges.\n \nWith the acquisition of Hospira Infusion Systems in 2017 and Smiths Medical in 2022, we are now a global market leader with a complete line of clinically-essential IV therapy and high-value critical care products for hospital, alternate site, and home care settings.\n \nWe're ready to bring you consistent quality, innovation, and value in more areas than ever. Our focus allows us to bring you:\n \n * Dedicated and non-dedicated IV sets and needlefree connectors clinically proven to provide an effective barrier against bacterial transfer and colonization. \n * The industry's broadest IV smart pump offering covering large volume, pain management, and ambulatory needs. \n * IV medication safety software providing full IV-EHR interoperability with the highest customer satisfaction and compatibility with more EHR systems than any other company. \n * Significant US IV solutions manufacturing and supply capabilities. \nThis role is based remotely; the incumbent may be remote in any state other than Colorado; California; Connecticut; Montana, Maine or New York.\n \nICU Medical EEO Statement:\n \nICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status. \n \nIf you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please conta To view the full job description please use the link below. https://www.aplitrak.com/?adid=YmJnZW5lcmljLjA4NjMxLjEyMjQ4QGljdW1lZGNvbXAuYXBsaXRyYWsuY29t
