Sr. Verification & Validation (V&V) Engineer

Job Description

Job Description

Salary : Position Overview

The Senior V&V Engineer plays a critical role in ensuring Carlsmeds medical device software systems meet safety, performance, and regulatory requirements. This role is responsible for planning, executing, and documenting verification and validation activities across software systems. The engineer will collaborate closely with R&D, Software Engineering, Mechanical Engineering, Operations, and Regulatory teams to ensure products comply with FDA, ISO, and IEC design control standards.

The ideal candidate has deep experience in software based medical device V&V, strong technical test skills, exceptional documentation discipline, and the ability to work across complex, multidisciplinary product architectures.

Key Responsibilities

Test Strategy & Planning

• Develop and maintain comprehensiveV&V plans, including Verification Plans, Validation Plans, Test Protocols, Test Reports, and Traceability Matrices.
• Define system-level test strategies for software, hardware, and integrated platforms in compliance withFDA 21 CFR 820.30,ISO 13485,IEC 62304, etc.
• Contribute to risk management activities (hazard analysis, FMEA) and ensure test coverage aligns with risk controls.

Execution & Documentation

Cross-Functional Collaboration

Tools & Process Ownership

System-Level Testing

Qualifications

Equal Opportunity Employer

Carlsmed is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status. Carlsmed is committed to providing reasonable accommodation for candidates with disabilities in our recruitment process. If you need assistance or accommodation due to a disability, please let us know.

Compensation

We are pleased to provide a competitive salary and benefits. Our benefits reflect our investment in the overall health and well-being of our employees and their families. including paying 100% of monthly healthcare, dental and vision insurance premiums, a 401(k) plan with employer matching, and unlimited PTO. The expected pay range is $145,000 to $165,000. Compensation may vary based on related skills, experience, and relevant key attributes.