Medical Device Cybersecurity Engineer

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. We help you grow your career through mentoring, sponsorship, and a culture of learning.

About the role

We are currently seeking a Medical Device Cybersecurity Engineer for our Electrical Engineering & Computer Science Practice in any U.S. location. In this short-term, hourly role, you will work as part of a team to help assess and improve cybersecurity documentation and package this documentation for successful eSTAR submission.

Responsibilities

• Deliver highly technical consulting services to help ensure the cybersecurity materials for a medical device meet FDA expectations and package them using eSTAR for a 510(k) submission.
• Carefully assess common premarket submission failure points, such as risk assessment, security control, and architectural view documentation, to ensure they will pass FDA review upon submittal.
• Ensure 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, as well as unwritten but common expectations.
• Provide concise and actionable feedback to correct materials that would not pass FDA review.
• Prepare cybersecurity materials for 510(k) submission such that they can be added directly to the eSTAR form.
• Produce cybersecurity templates that can be used for future eSTAR 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.

Benefits

Exponent is committed to offering a variety of programs and resources to support health and well-being. We believe that providing competitive benefits as well as compensation and recognition programs empowers our staff to do work that makes a difference. Access benefits information on our Life@Exponent page.

Pay

The base salary range for this position is USD $115.00 - USD $135.00 per hour, dependent on experience and capabilities which will be assessed during the interview process. At the Associate and Senior Associate level, total compensation includes base salary, bi-weekly bonuses for high-intensity efforts, annual bonus, and 401(k) employer contribution of 7% of base salary.

Work Environment

At Exponent, in-person interactions deepen employee engagement and are crucial for development, realizing the full potential of our talented and diverse teams, and building a more inclusive workplace. Our consultants engage in-person in the office unless traveling for client work or other business activities. We value work/life balance and understand its critical role in employee well-being. Consultants have the autonomy to balance work and personal schedules to meet client needs, visit inspection sites, attend conferences, and prioritize life outside of work.