Note: The job is a remote job and is open to candidates in USA. Exponent is a premium engineering and scientific consulting firm that seeks a Medical Device Cybersecurity Engineer. In this role, you will assess and improve cybersecurity documentation to ensure compliance with FDA expectations for medical device submissions.
Responsibilities
- Delivering highly technical consulting services to help ensure the cybersecurity materials for a medical device meets FDA expectations and package them using eSTAR for a 510(k) submission
- Carefully assessing common premarket submission failure points, such as risk assessment, security control, and architectural view documentation, to ensure they will pass FDA review upon submittal
- Ensuring all 510(k) submission materials meet both FDA expectations in the current Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions and other relevant guidance, and unwritten but common expectations
- Providing concise and actionable feedback to correct materials that would not pass FDA review
- Preparing cybersecurity materials for 510(k) submission such that they can be added directly to the eSTAR form
- Producing cybersecurity templates that can be used for future eSTAR submissions
Skills
- Ph.D. or M.S. in Computer Science, Software Engineering, Electrical or Electronics Engineering, Computer Engineering, or a related technical discipline
- Proven ability to submit cybersecurity eSTAR materials that pass FDA review within the last year
- Experience securing multiple medical devices while correctly addressing regulatory requirements upon submittal
- Strong understanding of cybersecurity engineering principles, including threat modeling, secure architecture, vulnerability assessment, penetration testing, secure software development, software bill of materials generation and scanning, and risk management
- Familiarity with FDA cybersecurity guidance and FDA-recognized consensus standards (e.g., AAMI TIR57, IEC 81001-5-1)
- Strong communication and organizational skills; ability to thrive independently and as a collaborative team member in fast-paced, multidisciplinary settings
- Presently legally authorized to work in the United States; no immigration sponsorship or processing required
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