Lead System Tester

Job Title: Lead System Tester (Medical Devices)

Role Overview

We are seeking a highly experienced Lead System Test Engineer to join the IntraSight Hardware Team, contributing to advanced 2D and 3D imaging solutions that improve patient care. In this role, you will lead system-level verification and validation (V&V) activities across both New Product Introduction (NPI) and sustaining engineering programs.

You will define and drive end-to-end system test strategy, ensuring medical devices meet stringent performance, safety, quality, and regulatory requirements throughout the product lifecycle. This role involves close collaboration with cross-functional engineering teams, quality, regulatory affairs, manufacturing, suppliers, and external test laboratories.

The ideal candidate will bring strong technical leadership in system testing for complex, safety-critical medical devices, with deep experience in regulated environments.

Key Responsibilities

• Lead system-level verification and validation for imaging platforms across NPI and sustaining programs
• Develop and execute system test strategies, test plans, protocols, and reports aligned with regulatory requirements
• Lead functional, integration, regression, reliability, and compliance testing activities across internal teams and external labs
• Drive end-to-end verification activities from concept through product release and post-market support
• Support sustaining engineering activities including design/supplier changes, complaint investigations, CAPA, and lifecycle management
• Ensure requirements traceability across risks, test cases, and verification evidence
• Lead root cause analysis and failure investigations for system-level and field issues
• Support regulatory submissions and audits with complete, audit-ready documentation
• Drive continuous improvement in test processes, automation, and infrastructure

Required Skills & Experience

• Bachelor’s or Master’s degree in Engineering (Electrical, Mechanical, Biomedical, or Systems Engineering)
• 15+ years of experience in system testing/V&V within medical device environments
• Strong expertise in system integration, regression, and reliability testing
• Deep knowledge of medical device development lifecycle, risk management, and traceability
• Hands-on experience with IEC 60601-1 and IEC 60601-1-2 standards
• Experience supporting CAPA, complaint investigations, and post-market surveillance
• Strong root cause analysis and troubleshooting skills
• Experience working with global cross-functional teams and external suppliers
• Familiarity with tools such as DOORS, Windchill, Jira, or similar test management systems
• Strong leadership, communication, and stakeholder influence skills

Why This Role

This position plays a critical role in strengthening system test execution and leadership capacity for complex imaging programs, enabling successful delivery of both NPI and sustaining commitments in a regulated medical device environment.