Medical Device Cybersecurity Engineer
About The Position
Exponent is the only premium engineering and scientific consulting firm with the depth and breadth of expertise to solve our clients’ most profoundly unique, unprecedented, and urgent challenges. Our vision is to engage multidisciplinary teams of science, engineering, and regulatory experts to empower clients with solutions that create a safer, healthier, more sustainable world. For over five decades, we've connected the lessons of past failures with tomorrow's solutions to advise clients as they innovate technologically complex products and processes, ensure the safety and health of their users, and address the challenges of sustainability. Join our team of experts with degrees from top programs at over 500 universities and extensive experience spanning a variety of industries. At Exponent, you’ll contribute to the diverse pool of ideas, talents, backgrounds, and experiences that drives our collaborative teamwork and breakthrough insights. Plus, we help you grow your career through mentoring, sponsorship, and a culture of learning. We are currently seeking a Medical Device Cybersecurity Engineer for our Electrical Engineering & Computer Science Practice in any U.S. location. In this role, you will work as part of a team to help assess and improve cybersecurity documentation and package this documentation for successful eSTAR submission. This is a short-term, hourly role.
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
Benefits
- 401(k) employer contribution of 7% of base salary
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What This Job Offers
Career Level
Entry Level
