Haley Smith
Design Assurance Engineer at Proprio
- Role
- Design Assurance Engineer at Proprio
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Haley Smith
Systems engineer and technical program manager with 5+ years delivering…
Experience
Design Assurance Engineer
Aug 2022 — Present · Seattle, WA, US
Supported FDA clearance of a surgical navigation system through two Class II 510(k) submissions for the same product, addressing product changes and enhancements.• Owned the full design verification and validation lifecycle including planning, test method development, protocol authoring, execution, reporting, and maintenance of the product traceability matrix.• Completed product-level risk management deliverables, including the system risk analysis, software FMEA, and final risk management report in alignment with ISO 14971:2019.• Architected and administered a branched Jama Connect project structure to maintain requirements traceability across concurrent development projects at different stages of maturity, commercialization, and field release.• Supported IEC 60601-1 and 60•••12 evaluation and testing, including identification of applicable clauses based on product changes, requirements mapping, review of external lab reports (Intertek, Element), and documentation of compliance evidence.• Authored and maintained design control documentation including risk files, verification plans and reports, and regulatory deliverables in compliance with the company’s QMS and FDA expectations.• Facilitated cross-functional collaboration between systems engineering, software testing, and product development to ensure verifiable design inputs and traceable risk controls.• Updated work instructions for verification and validation to improve workplace efficiency while maintaining compliance with 21 CFR.
Education
Stanford University
Master's degree, Mechanical Engineering
2017 — 2019
University of Colorado Boulder
Bachelor of Science (B.S.), Mechanical Engineering
2013
Skills
- Embedded Software
- Team Leadership
- Arduino
- Research
- Microsoft Office
- Machining
- Mechanical Engineering
- C
- Teamwork
- Matlab
- Solidworks
- Debugging
- Leadership
- Data Analysis
- Public Speaking
- Mechatronics
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