Secure-by-Design Medical Device Software Engineer

Visa Hunt; United States; On-site; USD 120,000 - 150,000; Full time

Job summary

Meridian Bioscience is seeking a Software Engineer with a focus on Cybersecurity to ensure software for diagnostic platforms meets cybersecurity, regulatory, and quality requirements throughout the product lifecycle.

This system‑level role coordinates cybersecurity activities with R&D, Quality, Regulatory, and Software Engineering, translates requirements into technical specifications, maintains DHF documentation, and supports IEC 62304 and ISO 14971 practices, with 10‑15% 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, IEC 62304 software lifecycle processes, ISO 14971 risk management principles.
• Experience working with regulated design documentation (DHF, technical files).
• Ability to interpret and communicate complex technical and regulatory requirements across multidisciplinary teams.
• Experience with threat modeling, vulnerability assessment, or security risk management.
• Experience with Software and Hardware integration.
• Knowledge of additional standards such as AAMI TIR57 / TIR97, IEC 81001-5-1, NIST Cybersecurity Framework, OWASP.

Responsibilities

• Integrate cybersecurity requirements into the design and development of software for diagnostic platforms (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

Cybersecurity knowledge

Security risk management

Threat modeling

Stakeholder communication

Cross-functional collaboration

Education

Bachelor's or Master's degree in Software Engineering or related field

Job description

Meridian Bioscience is seeking a Software Engineer with a focus on Cybersecurity to ensure software for diagnostic platforms meets cybersecurity, regulatory, and quality requirements throughout the product lifecycle.

This system‑level role coordinates cybersecurity activities with R&D, Quality, Regulatory, and Software Engineering, translates requirements into technical specifications, maintains DHF documentation, and supports IEC 62304 and ISO 14971 practices, with 10‑15% travel.