Cybersecurity Software Engineer
Meridian Bioscience, Inc.•Remote,
•Onsite
About The Position
The Software Engineer with a focus on Cybersecurity will play a critical part in ensuring that software integrated into our diagnostic platforms meets cybersecurity, regulatory, and quality requirements. This system-level engineering role will facilitate software development, cybersecurity testers, and regulatory functions, ensuring secure design and compliant documentation throughout the product lifecycle.
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
Nice To Haves
- Experience as a Software Lead or Technical Lead capacity
- Familiarity with Laboratory Information Systems (LIS) and remote device management (IoT)
- Knowledge of additional standards and best practices, such as: AAMI TIR57 / TIR97 (Medical device Cybersecurity), IEC 81001-5-1 (secure product development lifecycle)
- Exposure to secure development frameworks (e.g., NIST Cybersecurity Framework, OWASP)
- Basic knowledge of French or Korean language
Responsibilities
- 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
- Other duties as assigned
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
