Sr. Verification & Validation (V&V) Engineer

Job Description

Job DescriptionSalary:

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

• Execute verification and validation test protocols, including functional, regression, performance, and usability testing.
• Document objective evidence and maintain high-quality engineering records suitable for regulatory audits and submissions.
• Ensure full traceability between user needs, system/software requirements, risk controls, and test cases.

Cross-Functional Collaboration

• Work closely with Mechanical Engineering and Operations to clarify requirements and ensure they are testable and unambiguous.
• Partner with Software, Clinical, and Quality teams to identify defects early and improve design robustness.
• Support Regulatory and Quality teams by contributing to510(k) and technical documentation packages.

Tools & Process Ownership

• Manage test environmentsincluding configurations for hardware, imaging datasets, and software builds.
• Use and improve test management tools such asJira, TestRail, Jama, etc.
• Drive continuous improvement in V&V processes, including automation opportunities, documentation templates, and design control workflows.

System-Level Testing

• Conduct integrated testing across imaging, planning software, and hardware subsystems.
• Support image-based testing (CT, MRI, X-ray) and anatomical model validation as needed.
• Perform root-cause analysis in collaboration with engineering teams for system failures or anomalies.

Qualifications

• Bachelors or Masters degree in Biomedical Engineering, Systems Engineering, Computer Science, Mechanical Engineering, or related field.
• 5+ yearsof experience in V&V formedical devicesor other regulated industries.
• Strong knowledge ofFDA, ISO 13485, IEC 62304, etc.standards and Design Controls.
• Hands-on experience writing V&V documentation (test plans, protocols, reports, trace matrices).
• Proficiency in testing complex systems that combine software, hardware, and clinical workflows.
• Familiarity with defect tracking and test management tools (e.g., Jira, TestRail, Jama).
• Strong analytical, troubleshooting, and communication skills.
• Experience with imaging-based systems, surgical workflows, or cloud-connected devices is a plus.
• (Preferred) Background supporting regulatory submissions such as 510(k).

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.