Cybersecurity Software Documentation Engineer

Job Description

Cybersecurity Software Documentation Engineer has responsibilities such as the creation, review, and release of the FDA documentation for the eSTAR materials related to cybersecurity:

• Description of the threat model
• Cybersecurity summary
• Software Bill of Materials and OTS vulnerability and issue tracking and linking to the SW failure mode and vulnerability analysis
• Architecture diagram view creation, review and release
• Cybersecurity risk management plans

• 3+ years’ experience in cybersecurity and/or regulatory
• Technical writing experience in a medical device environment
• Experience creating 510K submissions for software a plus
• Ability to create scripts and leverage tools such as Black Duck, and Coverity to perform analysis and reporting in support of creating required FDA documentation.
• Bachelor’s Degree in Computer Science, Cybersecurity or equivalent a plus
• Experience using the NIST vulnerability database
• Basic software scripting skills in Python, or Perl

This position involves day-to-day interactions with a fast paced collaborative development team. It requires working onsite; it is not a telecommuting position.