Open to opportunities

Haley Smith

@haleysmith1

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Design assurance engineer specializing in regulated medical and aerospace systems.

United States

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What I'm looking for

I seek roles where I can lead V&V and risk management for regulated, safety-critical medical or wearable systems, working cross-functionally to deliver compliant, high-quality products and scalable verification processes.

I am a Design Assurance and Verification Engineer with five years of experience across regulated medical devices and aerospace systems, focusing on end-to-end verification and validation, requirements management, and risk management under FDA 21 CFR and ISO 14971 frameworks. I have led V&V lifecycles for FDA Class II surgical navigation systems, architected requirements traceability in Jama Connect, and delivered system-level risk management integrating hardware and software FMEAs.

I bring hands-on firmware and test automation experience (C++, Python, MATLAB) and a track record of implementing QMS-compliant verification documentation that reduced review cycle times by 30%. I partner effectively with product, firmware, and external test labs to achieve IEC 60601-1/-1-2 compliance and enable reliable wearable and remote monitoring solutions.

Experience

Work history, roles, and key accomplishments

Current

Design Assurance Engineer

Current

Proprio

Aug 2022 - Present (3 years 4 months)

Lead end-to-end verification and validation for an FDA Class II surgical navigation system, implemented QMS-compliant verification documentation that reduced review cycle times by 30%, and managed system-level risk per ISO 14971.

ISO 14971 Risk Management

V&V Engineer II / V&V Lead

Tethers Unlimited

Feb 2020 - Aug 2022 (2 years 6 months)

Led V&V strategy and execution for aerospace electromechanical payloads including qualification and environmental testing, and developed C++ control firmware and automated test infrastructure for avionics subsystems.

Environmental Testing C++Test Automation Firmware

Mechatronics Engineer

Vicis

Jul 2019 - Dec 2019 (5 months)

Designed and tested embedded systems and rapid manufacturing methods for helmet fit and impact protection, collaborating across mechanical and electrical teams to validate prototype performance.

Embedded Systems Rapid Prototyping Validation Sensors Cross Functional Collaboration

Education

Degrees, certifications, and relevant coursework

Stanford University

Master of Science, Mechanical Engineering

Grade: GPA: 3.69

Activities and societies: Depth: Mechatronics; Breadth: Robotics, Dynamics

Completed a Master of Science in Mechanical Engineering with focus depth in mechatronics and breadth in robotics and dynamics.

University of Colorado Boulder

Bachelor of Science, Mechanical Engineering

Grade: GPA: 3.70

Activities and societies: Student-athlete — Women’s Basketball

Completed a Bachelor of Science in Mechanical Engineering with strong academic performance and participated as a student-athlete on the women’s basketball team.