Medical Device Cybersecurity Engineer

Medical Device Cybersecurity Engineer ID 2026-2530 Location US-WA-Seattle Practice Electrical Engineering and Computer Science Position Type Intermittent Posted Salary Range USD $115.00 - USD $135.00 /Hr.

About Exponent 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.

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. Thanks for your interest in joining our team! Key statistics: 950+ Consultants 640+ Ph.D.s 90+ Disciplines 30+ Offices globally Our Opportunity 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. You will be responsible for 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 You will have the following skills and qualifications 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 Applicants are encouraged to submit a CV (Curriculum Vitae) with publications (feel free to include publications that are in review or pending) [not restricted to 1 page].

Work Environment At Exponent, we have found that in-person interactions deepen employee engagement and are crucial for development, for realizing the full potential of our talented and diverse teams, and for building a more inclusive workplace where all have a sense of belonging.

The base salary range for this position is dependent on experience and capabilities which will be assessed during the interview process. Salary Range USD $115.00 - USD $135.00 /Hr.

If you need assistance or accommodation due to a disability, you may email us at HR-Accommodations@exponent.com . Job Locations US-WA-Seattle Options Apply for this job online Apply Share Submit a referral to this job Refer Sorry the Share function is not working properly at this moment.