Manager, Biocompatibility Engineering – R&D

October 30

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

⛰️ Colorado – Remote

Although this job is listed in Colorado, this company may be open to hiring remote in other states.

+4 more states

🏄 California – Remote ⛰️ Colorado – Remote 🦌 Connecticut – Remote 🦞 Maine – Remote 🦬 Montana – Remote 🗽 New York – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🖥 Software Engineer

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ICU Medical

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Healthcare Insurance • Pharmaceuticals • Medical

ICU Medical is a global leader in intravenous (IV) therapy, specializing in innovative medical products and technologies that enhance the safety and efficiency of IV therapy across various care settings. Founded in 1984 by clinicians, the company is dedicated to delivering clinically-relevant solutions, including infusion pumps, safety software, and vascular access devices. ICU Medical's commitment to improving patient care is reflected in their comprehensive portfolio that spans infusion therapy, airway management, hemodynamic monitoring, and temperature management, ensuring clinicians can meet the diverse challenges of patient care effectively.

5001 - 10000 employees

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• Competitive salary • Health insurance • 401(k) matching • Flexible working hours • Paid time off