Meridian Bioscience Inc.Remote
Cybersecurity Software Engineer
United States of America
Full Time
1 hour ago
H1B Sponsor Likely
Key skills
CybersecurityEmbedded Software DevelopmentFDA Cybersecurity GuidanceIEC 62304 Software Lifecycle ProcessesISO 14971 Risk ManagementDesign History File (DHF) DocumentationThreat ModelingVulnerability AssessmentSecurity Risk ManagementSoftware and Hardware IntegrationLaboratory Information Systems (LIS)Remote Device Management (IoT)AAMI TIR57 / TIR97IEC 81001-5-1NIST Cybersecurity FrameworkOWASPRRisk ManagementCommunicationCollaboration
About this role
Meridian Bioscience, Inc. is a fully integrated life science company dedicated to developing innovative diagnostic products. The Software Engineer with a focus on Cybersecurity will ensure that software integrated into diagnostic platforms meets cybersecurity, regulatory, and quality requirements, while collaborating with various teams to maintain secure design and compliant documentation.
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
Requirements:
- 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