Medical Device Validation Engineer Jobs in Seattle, WA

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. Thanks for your interest in joining our team! 

Key statistics: 

• 950+ Consultants 
• 640+ Ph.D.s 
• 90+ Disciplines 
• 30+ Offices globally 

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.

• 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

• 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].

To learn more about life at Exponent and our impact, please visit the following links:https://www.exponent.com/careers/life-exponent https://www.exponent.com/company/our-impact

Attracting, inspiring, developing, and rewarding exceptional people with diverse backgrounds and expertise are central to our corporate culture. Our diverse team allows us to provide better value to our clients and enjoy an enriched work environment.  

Our firm 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. 

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. In our offices, you can expect a supportive culture and a collaborative, dynamic, multi-disciplinary work environment. Our consultants engage in-person in the office unless they are traveling for client work or other business activities.

We value the rich lives our colleagues enjoy outside of work and understand that work/life balance is critical to our employees and their well-being. Consultants have the autonomy to balance their work and personal schedules so you can meet with clients, visit inspection sites, attend conferences, and make time for priorities outside of work, too. It is this flexible, agile work style and working hours that allow our teams to drive innovation and results in their own ways, while meeting the needs of clients. #LI-Onsite

Our consultants are rewarded for their technical and business contributions and have an opportunity to plan for future success and career growth. Exponent's total compensation plan is consistent with its expectations of the quality and quantity of work performed and with the professional standards set by Exponent. 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.

The base salary range for this position is dependent on experience and capabilities which will be assessed during the interview process.

Access benefits information on our Life@Exponent page: 

https://www.exponent.com/careers/life-exponent 

Exponent is a proud equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, veteran status, disability, sexual orientation, gender identity, or any other protected status. 

If you need assistance or accommodation due to a disability, you may email us at HR-Accommodations@exponent.com.