Medical Device Cybersecurity Engineer

Job not on LinkedIn

🕒 September 4

🇺🇸 United States – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👮‍♂️ Cybersecurity / Security Engineer

👻 Ghost score 10%

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Meridian Bioscience Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏥 Healthcare

💼 Consulting

🍽️ Food & Beverage

💰 Grant on 2022-01

Healthcare • Consulting • Food & Beverage

Meridian Bioscience Inc. is a leading manufacturer of molecular and immunological reagents designed for diagnostic applications. The company specializes in providing innovative solutions to enhance point-of-care diagnostics and streamline assay development for various medical conditions, including infectious diseases and cancers. Meridian is dedicated to advancing medical diagnostics and improving patient outcomes through its high-quality products and services.

📋 Description

• Integrate cybersecurity requirements into software design and development for diagnostic platforms, including coding on embedded software • Ensure compliance with FDA cybersecurity guidance and applicable North American regulations • Collaborate with software development teams on secure-by-design implementation • Translate cybersecurity and regulatory requirements into technical specifications and documentation • Contribute to and maintain Design History File (DHF) documentation under design control requirements • Support software lifecycle activities aligned with IEC 62304 • Participate in ISO 14971 risk management activities, including threat modeling, risk analysis, and mitigation strategies • Review system architecture and design for secure development principles • Serve as a cross-functional liaison between R&D, Quality, Regulatory, and Software Engineering teams • Perform other duties as assigned

🎯 Requirements

• Bachelor’s or Master’s degree in Software Engineering, Computer Engineering, or related field • 5 years of experience in software engineering or system-level roles • Recent experience in cybersecurity, preferably within the medical device or other regulated industry • Strong understanding of FDA cybersecurity guidance (pre-market and post-market) • Understanding of IEC 62304 software lifecycle processes • Understanding of ISO 14971 risk management principles • Experience working with regulated design documentation, such as DHF and technical files • Ability to interpret and communicate complex technical and regulatory requirements across multidisciplinary teams • Experience with software and hardware integration • Experience with threat modeling, vulnerability assessment, or security risk management • Preferred: experience as a Software Lead or Technical Lead • Preferred: familiarity with Laboratory Information Systems (LIS) and remote device management (IoT) • Preferred: knowledge of AAMI TIR57/TIR97, IEC 81001-5-1, NIST Cybersecurity Framework, or OWASP • Basic knowledge of French or Korean language preferred

🏖️ Benefits

• International travel at 10–15% • Equal employment opportunity consideration for qualified applicants