Sr. Verification & Validation (V&V) Engineer
CarlsmedCarlsbad, California, United States
Posted November 14, 2025
Full Time
About the Company
Carlsmed is a commercial‑stage medical technology company that pioneers personalized spine surgery. Leveraging its proprietary aprevo® Technology Platform, the firm integrates AI‑driven software with patient‑specific fusion devices to tailor surgical procedures to each individual. This combination delivers higher precision, reduced recovery times, and improved outcomes for spinal patients. By positioning itself at the intersection of advanced robotics, data analytics, and custom implant design, Carlsmed is redefining the standard of care in spine surgery. The company’s culture emphasizes innovation, collaboration, and a commitment to improving patient quality of life.
Job Description
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.
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.