Engineer II, Biocompatibility

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ICU Medical

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

⚕️ Healthcare Insurance

💊 Pharmaceuticals

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.

📋 Description

• We are seeking a Biocompatibility Engineer II to join our team. As a member of the biocompatibility team, you will help ensure patient safety by contributing to the biological and toxicological evaluations of medical devices, materials, and processes. You will work closely with cross-functional teams to comply with global regulatory standards such as ISO 10993. • You will leverage your understanding of the medical device biocompatibility field to provide guidance throughout the product development cycle, interpret regulatory requirements, and support the biocompatibility strategy. Using your analytical skills, you will review scientific data, identify gaps, and recommend risk mitigation strategies. • This position will be pivotal in supporting regulatory compliance, quality engineering strategies, and design history file (DHF) remediation aligned with medical device regulations and standards such as EU MDR, FDA 510(k), ISO 13485, ISO 10993, ISO 18562, and ISO 14971.

🎯 Requirements

• Must be at least 18 years of age. • Bachelor’s degree in chemical or biomedical engineering, or related field, from an accredited college or university is required. • 2+ years of Industry (Medical Devices) experience with a Bachelor. • A Master's Degree or PhD in a relevant field may substitute for industry experience.

🏖️ Benefits

• Remote work options