Job Summary The Principal Cybersecurity Engineer, under minimal supervision, provides hands-on product security engineering, encompassing various aspects of medical device cybersecurity for devices with embedded and web applications. Actively engages in all stages of secure product development, with a particular emphasis on threat modeling, vulnerability analysis, and risk assessment. Contributes to the architectural design process to guarantee that security requirements are met. Supports the implementation of a comprehensive security testing strategy and assists in the formulation and execution of cybersecurity policy for medical device development and on-market medical devices.
Due to applicable export control laws and regulations, candidates must be a U.S. citizen or national, U.S. permanent resident (i.e., current Green Card holder), or lawfully admitted into the U.S. as a refugee or granted asylum. Responsibilities
In compliance with September 2023 FDA guidance, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions", the following activities will be performed
Threat modeling
Vulnerability analysis and risk estimation
Risk evaluation
Vulnerability prioritization
Security risk control assessment
Development and execution of security test strategy
Review product cybersecurity standard operating procedures and provide pragmatic recommendations for continuous process improvements to maintain compliance with global regulatory standards and agency regulations
Provide cybersecurity guidance to the broader product development team to ensure uniform adherence to industry best practices across all product designs and processes
Requirements
Bachelor's degree in Computer Science, Computer Engineering, Cybersecurity or related Engineering degree
Experience or in-depth knowledge of FDA regulatory requirements for cybersecurity in medical devices
5+ years of experience in performing cybersecurity activities
Experience in application of cybersecurity to embedded medical device software and/or web applications
Expected to be abreast of rapidly evolving cybersecurity landscape and applicability to medical devices
Must possess excellent written and verbal communication skills
Experience in the planning and execution of Cybersecurity Penetration testing.
Experience in Software Composition Analysis.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
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