Apply on Employer Site

Carlsmed · 2 months ago

Sr. Verification & Validation (V&V) Engineer

Carlsbad, California, United States

Full-time

Onsite

Senior Level

5+ years exp

Carlsmed is a company focused on medical device software systems, and they are seeking a Senior V&V Engineer to ensure compliance with safety, performance, and regulatory requirements. The role involves planning, executing, and documenting verification and validation activities while collaborating with various engineering and regulatory teams.

Health CareManufacturingMedical Device

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

Qualification

V&V for medical devicesFDAISO 13485IEC 62304Writing V&V documentationTesting complex systemsDefect tracking toolsAnalytical skillsTroubleshooting skillsImaging-based systemsRegulatory submissionsCommunication skills