Embedded 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

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.