Verification and Validation Engineer

Verification and Validation Engineer

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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 defining, planning, documenting, leading, and performing all V&V activities.

• 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.

• 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.

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

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.

Mid-Senior level

Full-time

Quality Assurance