Spectral AI · 2 days ago
Verification and Validation Engineer
Dallas, TX
Full-time
Onsite
Senior Level
5+ years expSpectral AI, Inc. is focused on the development of medical devices, and they are seeking a Verification and Validation Engineer to oversee all activities related to design verification and validation. The role involves defining, planning, and executing V&V activities to ensure compliance with regulatory and business requirements.
AnalyticsArtificial Intelligence (AI)BiotechnologyHealth CareMachine LearningMedical Device
Responsibilities
Define, plan and lead activities, including, test method development and validation, fixture design and testing optimization in support of Design Verification and Validation
Evaluate and analyze the system (entire Device and any peripherals) performance and reliability to ensure the design is adequately pressure-tested to satisfy user, regulatory and business requirements
Understand the system and subsystem design performance to identify and address early in the development process any potential design integration and design transfer risks
Create and document test methodologies and provide feedback and recommendations for product/design changes
Follow the Design Control Process and Ensure compliance with SMD’s quality policies, procedures, and practices
Develop, document, and verify/validate test tools and test methodology for the verification of hardware (electrical, mechanical, imaging)
Write and execute integration, plans, protocols, and associated reports
Write and execute characterization, plans, protocols, and associated reports
Write and execute verification plans, protocols, and associated reports
Write validation plans, protocols and execute validation testing to demonstrate coverage of user needs and intended uses
Analyze information and test data to support technical solutions
Identify, report, and track defects identified throughout all phases of the development lifecycle
Assists in quality systems responsibilities requested by management to ensure a robust and compliant Quality Management System
All other duties assigned
Qualification
Required
Experience developing Class II and/or Class III medical devices
A Bachelor's degree, or an advanced degree, in engineering, biotech, life sciences; or equivalent experience
A minimum of five years' experience in the medical device industry
Working knowledge of following regulations/standards: 21 CFR 820 and ISO 13485, Risk Management per ISO 14971
Experience working in cross functional organization
Knowledge of the Microsoft office suite of products (PowerPoint, Excel, etc.,)
Highly detail-oriented, excellent analytical and troubleshooting skills, highly motivated team player adept at cross-functional interaction
Excellent verbal and written communication skills
Excellent interpersonal and customer service skills
Excellent organizational skills and attention to detail
Excellent time management skills with a proven ability to meet deadlines
Strong analytical and problem-solving skills
Ability to prioritize tasks and to delegate them when appropriate
Proficient with Microsoft Office Suite or related software
Prolonged periods of sitting at a desk and working on a computer
Must be able to lift, up to 25 pounds at times
Company
Spectral AI
Spectral AI specializes in predictive analytics with a platform that uses proprietary artificial intelligence (AI).
51-200 employees
Funding
Current Stage
Public CompanyTotal Funding
$128.7MKey Investors
Avenue Capital GroupMedical Technology Enterprise ConsortiumBiomedical Advanced Research and Development Authority (BARDA)
2025-10-23Post Ipo Equity· $7.6M
2025-03-24Post Ipo Equity· $2.7M
2025-03-24Post Ipo Debt· $8.5M
Leadership Team
Jeremiah Sparks
Chief Commercial Officer
Recent News
Spectral AI, Inc.
2025-11-19
Spectral AI, Inc.
2025-11-12
2025-10-29
Company data provided by crunchbase