Medical Device Cybersecurity Engineer

Meridian Bioscience International Limited; Northern (KY); Hybrid; USD 120,000 - 160,000; Full time

Job summary

Meridian Bioscience is seeking a Software Engineer focused on cybersecurity for diagnostic platforms. You will drive secure-by-design software, align with FDA guidance, and collaborate across R&D, Quality, and Regulatory teams to ensure compliant, safe products.

The role requires 5+ years in software/system roles, familiarity with IEC 62304, ISO 14971, and risk management. International travel (~10-15%) is expected. A degree in software/computer engineering is required.

Qualifications

• 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.
• Experience in cybersecurity within regulated environments (medical devices preferred).
• Knowledge of FDA cybersecurity guidance (pre/post-market) and ISO/IEC standards.
• Experience with DHF and regulated design documentation.

Responsibilities

• Incorporate cybersecurity requirements into software for diagnostic platforms.
• Ensure compliance with FDA cybersecurity guidance and NA regulations.
• Collaborate with development teams for secure-by-design implementations.
• Translate regulatory requirements into technical specs and docs.
• Maintain Design History File (DHF) and design-control docs.
• Support Software lifecycle activities per IEC 62304.
• Participate in risk management per ISO 14971.
• Review architecture for secure development alignment.
• Serve as liaison between R&D, Quality, Regulatory, and Engineering.
• Travel 10-15% internationally.

Skills

Cybersecurity

Regulatory knowledge

Cross-functional collaboration

Threat modeling

Secure development

Communication skills

Education

Bachelor’s or Master’s degree in Software/Computer Engineering

Tools

DHF

IEC 62304

ISO 14971

NIST CSF

Job description

About Meridian

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision.Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

Job Summary

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.

Key Duties

• 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

Qualifications

• 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
• Preferred:
• 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

*All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status. (USA Only)*