Note: The job is a remote job and is open to candidates in USA. Meridian Bioscience is a life science company that develops, manufactures, markets, and distributes diagnostic products. The Medical Device Cybersecurity Engineer will integrate cybersecurity, regulatory, and quality requirements into software for diagnostic platforms, supporting secure design, risk management, compliance, and documentation throughout the product lifecycle.
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
- Travel 10-15% international travel
Skills
- Travel 10-15% international travel
- 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
- 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
Company Overview
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