Validation Engineer II

Responsibilities

• Lead verification and validation activities for assigned projects
• Define verification strategies and author high-quality test plans and protocols
• Create and review design control documentation including requirements and test reports
• Design, develop, and qualify manual and automated system-level test methods
• Support risk management activities in accordance with ISO 14971
• Perform validation of non-medical-device software tools and supporting systems

Requirements

• Bachelor’s or master’s degree in biomedical engineering or related field
• 2-8 years of experience in V&V or systems engineering for medical devices
• Foundational understanding of FDA 21 CFR Part 820, ISO 13485, IEC 62304, and IEC 60601
• Familiarity with defect tracking tools like Jira or Polarion
• Knowledge of test method qualification methods such as Gage R&R
• Experience supporting Design History File (DHF) documentation

Preferred Qualifications

• ASQ CSQE or CQE certification
• Experience supporting regulatory submissions such as 510(k)s

About the Company

Alphatec Spine supports a broad range of software-enabled medical devices including intraoperative neuromonitoring, surgical alignment, and robotic navigation.