Cybersecurity Software Engineer

• 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

*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