Validation engineer [h1.location_city]

Position Summary :

The Verification and Validation Engineer will be responsible for all activities related to the design Verification and design Validation (V&V) of Spectral AI, Inc. medical device(s). This includes, but is not limited to, defining, planning, documenting, leading, and / or performing all V&V activities.

Essential Duties and 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.

Qualifications :

Required education and experience :

21 CFR 820 and ISO 13485

Knowledge, Skills and Abilities :

Physical Requirements :

The physical demands described below are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Travel :

15 % of travel time expected for the position, overnight to clinics or vendors.

Equal Employment Opportunity :

Spectral AI, Inc. is an equal opportunity and affirmative action employer. All applicants will be considered for employment without regard to race, color, ancestry, national origin, sex, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws.