Embedded Cybersecurity Software Engineer - Medical Devices

Meridian Bioscience Inc.; United States; On-site; USD 110,000 - 160,000; Full time

Job summary

Meridian Bioscience Inc. seeks a Software Engineer focused on cybersecurity to ensure secure, regulatory-compliant software across diagnostic platforms.

You will integrate cybersecurity into embedded software design, support DHF, and work with R&D, Quality, Regulatory and Software teams to meet FDA and ISO standards. The role requires 5 years in software or system-level roles, with experience in medical-device cybersecurity and secure development lifecycle practices.

Qualifications

• Bachelor’s or Master’s degree in software/related field.
• 5 years of experience in software engineering or system-level roles.
• Recent experience in cybersecurity within a regulated industry (medical device preferred).
• Knowledge of FDA cybersecurity guidance, IEC 62304, ISO 14971.

Responsibilities

• Integrate cybersecurity requirements into design and development of software for diagnostic platforms (embedded software).
• Ensure compliance with FDA cybersecurity guidance (pre-market and post-market) and applicable NA regulations.
• Collaborate with software teams to ensure secure-by-design implementation and maintain DHF documentation.
• Translate cybersecurity and regulatory requirements into clear technical specifications.

Skills

Cybersecurity

Software engineering

Regulatory compliance

Embedded software

Threat modeling

Education

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

Job description

Meridian Bioscience Inc. seeks a Software Engineer focused on cybersecurity to ensure secure, regulatory-compliant software across diagnostic platforms.

You will integrate cybersecurity into embedded software design, support DHF, and work with R&D, Quality, Regulatory and Software teams to meet FDA and ISO standards. The role requires 5 years in software or system-level roles, with experience in medical-device cybersecurity and secure development lifecycle practices.