Haley Smith
Design Assurance Engineer @ Proprio
About
Systems engineer and technical program manager with 5+ years delivering hardware-intensive products in regulated environments. I've owned requirements infrastructure, verification programs, and cross-functional execution across medical devices (FDA 21 CFR 820, ISO 13485) and aerospace systems, working alongside mechanical, electrical, software, and firmware teams from early development through product launch.At Proprio, I led system-level V&V and requirements governance for a surgical navigation platform, managing 500+ requirements across hardware, firmware, and software. I owned the IEC 60601-1 external certification program, coordinated milestone delivery across five engineering disciplines, and ran the product risk management program per ISO 14971. At Tethers Unlimited, I stood up a V&V team from scratch and led verification execution for a NASA research payload with no prior test precedent. I'm drawn to companies building complex physical products, especially in consumer hardware, robotics, wearables, or medical devices, where the intersection of NPI execution and technical rigor actually matters.Education: M.S. Mechanical Engineering (Mechatronics/Robotics) - Stanford | B.S. Mechanical Engineering - CU Boulder | Former D1 Women's BasketballCurrently seeking: Systems Engineering or Technical Program Manager roles at at hardware-intensive companies in consumer electronics, robotics, or medical devices in the Seattle area or remote.
United States
Greater Seattle Area
Medical Device
Hardware Development, Design Control, electromechanical systems, new product introduction, Program Management, Industry standards, Product Requirements, Standards Compliance, Test Methodologies, Design Assurance, Risk Management, Requirements Management, Verification and Validation (V&V), Test Engineering, Mechanical Engineering, Mechatronics, Team Leadership, Teamwork, Matlab, C
Experience

Design Assurance Engineer
Seattle, WA
Owned end-to-end verification and validation program for system and hardware subsystems, including verification strategy definition, test plan development, protocol authoring and maintenance, test execution, and verification report generation per QMS processes Managed complete requirements lifecycle for system and hardware requirements by collaborating with SMEs across systems, mechanical, electrical, software, UX, and product teams to translate user needs into clear, testable requirements using technical expertise and cross-functional facilitation Maintained end-to-end traceability matrix from user needs through system and hardware requirements to verification and validation artifacts, serving as the verification summary and ensuring complete coverage for audit readiness Coordinated hardware and system verification milestones across mechanical, electrical, firmware, software, and quality teams, tracking dependencies, managing external lab schedules, and resolving blockers to maintain NPI delivery commitments in a fast-moving startup environment Managed external compliance testing programs for IEC 60601-1, determining applicable test plans, executing in-house engineering confidence testing for applicable clauses, and coordinating with test labs Owned system-level risk management program per ISO 14971, including authorship and maintenance of Product Risk Assessment, leading cross-functional risk reviews, and applying risk-based prioritization to verification scope Established verification program infrastructure including requirements traceability framework in Jama Connect, verification planning and reporting templates, and cross-functional review processes that reduced documentation approval cycle time by ~30% Led operational program setup for in-house production operations, creating work instructions, NetSuite inventory workflows, and physical space planning to enable receiving, kitting, and shipping of precision instruments

V&V Team Lead
Tethers Unlimited, Inc.
Bothell, WA
Stood up an independent V&V team from scratch for MakerSat, a NASA research payload designed to extrude carbon fiber-reinforced structures in orbit as part of the OSAM-1 robotic servicing mission, joining the program pre-CDR with no existing verification framework in place. Established the full V&V program including team RACI, QMS documentation, verification planning, test strategy, and sprint planning, integrating the team into the broader program lifecycle and stakeholder review cadence. Designed and executed verification campaigns for four payload subsystems with no existing test precedent, developing custom test fixtures, GSE, and procedures aligned with NASA mission assurance requirements. Led hands-on prototype operation and root cause analysis on a first-of-kind electromechanical system, translating findings directly into requirements clarifications and design iterations in close collaboration with systems and design engineers.

Electro Mechanical V&V Engineer
Tethers Unlimited, Inc.
Bothell, Washington
• Designed and executed qualification test plans and procedures for OSAM-1 payload EQM system, subsystems, and avionics • Implemented and maintained electromechanical systems for low TRL prototypes/test setups, including multi-node motor control firmware using embedded C++ on arm microcontroller with COTS stepper and BLDC drivers • Provided input to systems engineering on requirements development and verifiability, specifically verification method/environment/level and tracing requirements to verification artifacts • Developed block diagrams, test fixtures, and infrastructure for laboratory environments to meet test objectives • Prepared technical documentation and review material for peers, management, and external customers, particularly ownership of TRRs

Mechatronics Engineer, Advanced Concepts (Layed Off Due to Budgetary Issues)
Seattle, Washington
• Conducted in-house research to develop and scale an innovative rapid manufacturing process for impact structures • Spec’d sensors and designed corresponding embedded systems to inform the proper fit of helmets

Research Assistant - Interactive Perception and Robot Learning Lab
Palo Alto, California
Completed the build & bring up of 3 holonomic robotic platforms with integrated robotic arms involving consultation of schematics/datasheets & debugging of hardware/firmware. Implemented a full body operational space controller for mobile platform that used visual servoing to track a balloon’s trajectory and hit it with a racket.

Course Assistant - ENGR 14: Intro to Solid Mechanics
Palo Alto, CA
Helped to facilitate undergraduate student learning by conducting office hours, leading supplementary lectures, grading homework and exams, providing constructive feedback, and aiding weekly hands-on activities.
Mechanical Engineering Intern
Sunnyvale, California
Adapted the daVinci Sure-Form 60 Stapler for a novel surgical platform by engineering a miniature-scale high-thrust/high-stroke drive mechanism for firing, and mechanisms to allow for steering and shaft roll of the instrument Developed anthropometric data driven human body models with biologically accurate mechanical properties and a reproducible rapid manufacturing process for creating said models to aid robot design and testing

Undergraduate Researcher
Advanced Medical Technologies Laboratory
I completed a redesign of a prototyped Endoscopically-Delivered Overtube (EDO) that had been engineered by a student group at CU. The device consisted of a novel overtube to be used with any commercially available endoscope/colonoscope to ease insertion, manipulation, and retraction during colonoscopy. Over the course of the semester I experimented with various catheter balloon materials and shapes as well as the number and placement of these balloons on the overtube to optimize both concentricity of the endoscope in the lumen and steerability of the endoscope.

Mechanical Engineering Summer Intern
Mountlake Terrace, Washington
• Utilized mill to complete precise adjustments to metal block used in mesofluidic prosthetic ankle • Completed requirement validation tests for Bluetooth-enabled force and moment sensor and created company reports detailing contrived experiments and their results • Executed sensitivity analysis on valve pin mechanism in prosthetic ankle - determined tolerance stack up in hydraulic circuit by referencing CAD model and drawings, then wrote Matlab code that accounted for variability in dynamics of system due to manufacturing error, plotted results in creative and digestible way, and determined maximum tolerance to stay within boundaries for usability
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