Cybersecurity Architect

KEY RESPONSIBILITIES

• Responsible for leading the design, implementation, and maintenance of comprehensive security measures across all stages of medical device development, ensuring compliance with relevant regulations and standards while protecting patient data and device integrity
• Lead the design and implementation of secure architectures for new medical devices, considering connectivity, data protection, access controls, and secure communication protocols
• Conduct thorough vulnerability assessments and penetration testing on medical devices to identify potential security flaws and implement corrective actions
• Ensure compliance with relevant medical device cybersecurity regulations and standards, including documentation and reporting requirements.
• Mentor and guide junior cybersecurity engineers on best practices, security techniques, and emerging threats within the medical device domain
• Collaborate with cross-functional teams including product development, quality assurance, regulatory affairs, and clinical teams to address cybersecurity concerns

KEY SKILLS AND QUALIFICATIONS

• Deep understanding of cybersecurity principles and concepts, including cryptography, network security, authentication, authorization, and data protection.
• Expertise in medical device cybersecurity standards and regulations (FDA, IEC 62304, ISO 14971, IEC 81001-5-1)
• Proven experience in threat modeling, risk assessment, and vulnerability management within the medical device context
• Strong knowledge of secure coding practices and software development methodologies
• Experience with penetration testing tools and techniques for medical devices
• Excellent communication and collaboration skills to work effectively with cross-functional teams
• Bachelor's degree in computer science, electrical engineering, or a related field
• 10+ years of experience with cybersecurity and software systems
• Advanced cybersecurity certifications (e.g., CISSP, CISA, OSCP) are highly desirable