Sr. Verification & Validation (V&V) Engineer

Carlsmed•Carlsbad, CA

38d

About The Position

The Senior V&V Engineer plays a critical role in ensuring Carlsmed's 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.

Requirements

Bachelor's or Master's degree in Biomedical Engineering, Systems Engineering, Computer Science, Mechanical Engineering, or related field.
5+ years of experience in V&V for medical devices or other regulated industries.
Strong knowledge of FDA, 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.

Nice To Haves

Experience with imaging-based systems, surgical workflows, or cloud-connected devices is a plus.
(Preferred) Background supporting regulatory submissions such as 510(k).

Responsibilities

Develop and maintain comprehensive V&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 with FDA 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.
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.
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 to 510(k) and technical documentation packages.
Manage test environments-including configurations for hardware, imaging datasets, and software builds.
Use and improve test management tools such as Jira, TestRail, Jama, etc.
Drive continuous improvement in V&V processes, including automation opportunities, documentation templates, and design control workflows.
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.