Cybersecurity Software Engineer

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Meridian Bioscience Inc.

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🧬 Biotechnology

⚕️ Healthcare Insurance

💊 Pharmaceuticals

💰 Grant on 2022-01

Biotechnology • Healthcare Insurance • Pharmaceuticals

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 the design and development of software for diagnostic platforms (coding on embedded software) • Ensure compliance with FDA cybersecurity guidance (pre-market and post-market) and applicable North American regulations • Collaborate with software development teams to ensure secure-by-design implementation • Translate cybersecurity and regulatory requirements into clear technical specifications and documentation • Contribute to and maintain Design History File (DHF) documentation in compliance with design control requirements • Support software lifecycle activities aligned with IEC 62304 • Participate in risk management activities in accordance with ISO 14971 (e.g., threat modeling, risk analysis, mitigation strategies) • Review system architecture and design to ensure alignment with secure development principles • Act as a cross-functional liaison between R&D, Quality, Regulatory, and Software Engineering teams

🎯 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) • IEC 62304 software lifecycle processes • ISO 14971 risk management principles • Experience working with regulated design documentation (e.g., DHF, technical files) • Ability to interpret and communicate complex technical and regulatory requirements across multidisciplinary teams • Experience with Software and Hardware integration • Strong collaboration and stakeholder communication skills • Experience with threat modeling, vulnerability assessment, or security risk management

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Remote work options