Cybersecurity Software Engineer

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Meridian Bioscience Inc.

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501 - 1000 employés

🏥 Santé

💼 Conseil

🍽️ Alimentation et boissons

💰 Grant en 2022-01

Healthcare • Consulting • Food & Beverage

Meridian Bioscience Inc. est un fabricant de premier plan de réactifs moléculaires et immunologiques destinés aux applications de diagnostic. L'entreprise se spécialise dans la fourniture de solutions innovantes pour améliorer les diagnostics au point de soins et rationaliser le développement de tests pour diverses conditions médicales, y compris les maladies infectieuses et les cancers. Meridian est dédiée à l'avancement du diagnostic médical et à l'amélioration des résultats pour les patients grâce à ses produits et services de haute qualité.

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

🎯 Exigences

• 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

🏖️ Avantages

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