Medical Device Cybersecurity Engineer

Exponent•Seattle, WA

3d•$115 - $135•Onsite

About The Position

Exponent is seeking a Medical Device Cybersecurity Engineer for their Electrical Engineering & Computer Science Practice. This is a short-term, hourly role where the engineer will work as part of a team to assess and improve cybersecurity documentation for medical devices, ensuring it meets FDA expectations and is packaged for successful eSTAR submission. The role involves evaluating common premarket submission failure points, ensuring compliance with FDA guidance, providing feedback on materials, preparing documentation for eSTAR, and producing cybersecurity templates for future submissions.

Requirements

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

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