Validation Engineer II at ATEC Spine

Compensation

$90,000 – $110,000/yr

Location: Carlsbad, California
Type: Full-time
Level: not_specified
Posted: Jun 10, 2026

Description

The Validation Engineer II is a mid-level role focused on leading software verification and validation activities for medical device projects. This role involves defining verification strategies, developing test plans, improving V&V practices, and ensuring compliance with FDA, ISO, and IEC standards. The engineer will collaborate with various departments like R&D, Software Engineering, and Quality Engineering to ensure innovative products meet regulatory requirements.

Required Skills

Software Verification Activities
Continuous Improvement
Validation Processes
Verification Strategies
Test Plans and Protocols
Design Control Documentation
Manual and Automated Test Methods
Risk Management Activities
Hazard Analysis
Risk Controls
Verification of Risk Mitigations

Additional Information

Required Previous Experiences: 2-8 years of experience in V&V or systems engineering for medical devices, or other regulated industries
Preferred Qualifications: Foundational understanding of FDA Quality System Regulations (21 CFR Part 820) & ISO 13485
Foundational understanding of IEC 62304 and IEC 60601 standards
Foundational understanding of ISO 14971 risk management requirements
Familiarity with defect tracking and test management tools (e.g., Jira, Polarion)
Working knowledge of test method qualification methods (Gage R&R, Attribute Agreement Analysis) and competency using desktop lab equipment (function generators, oscilloscopes, etc.)
Basic to working knowledge of probability and statistics concepts, and design of experiments (DoE)
Experience supporting Design History File (DHF) documentation and Change Order routing
Exposure to or experience supporting regulatory submissions such as 510(k)s
Demonstrated organizational and time-management skills to support cross-functional project activities
Ability to communicate technical concepts effectively with internal stakeholders and cross-functional team members
Detail-oriented, deadline-driven, and able to work collaboratively in a team environment