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Medical Device Cybersecurity Engineer

Meridian Bioscience

Medical Device Cybersecurity Engineer

United StatesRemoteFull-time

Posted Sep 6

Apply

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)*

Originally posted on Himalayas

Job Description

About Meridian

Job Summary

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

Originally posted on Himalayas

Job Description

About Meridian

Job Summary

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

Originally posted on Himalayas

Job Description

About Meridian

Job Summary

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

Originally posted on Himalayas