Systems Test Engineer - medical Devices 2d/3d Imaging

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Lead System Tester Role Overview: In this role, you have the opportunity to make life better. Looking at the challenges the world is facing today, purpose has never been more relevant. In the Lead System Test Engineer role, you will be part of the multidisciplinary Hardware Team, contributing to innovative 2D and 3D imaging clinical solutions. You will lead system-level verification and validation activities across both New Product Introduction (NPI) programs and sustaining engineering projects, ensuring that products meet performance, safety, quality, and regulatory requirements throughout the product lifecycle. You will play a key role in driving system test strategy, leading testing teams, and collaborating closely with internal stakeholders and external suppliers to ensure reliable and compliant medical device solutions.

Job Responsibilities: Leading system-level verification and validation activities for the IntraSight platform across both NPI and sustaining projects. Defining and executing comprehensive system test strategies, plans, protocols, and reports aligned with product and regulatory requirements. Leading multidisciplinary system testing teams in the execution of functional, integration, regression, reliability, and compliance testing activities, both internally and using external test houses. Driving system verification activities throughout the product development lifecycle, from concept through release and post-market support. Supporting sustaining activities including design changes, supplier changes, complaint investigations, CAPA, and lifecycle management. Collaborating with engineering, quality, regulatory, manufacturing, and suppliers to ensure effective test coverage and issue resolution. Leading root cause investigations and failure analysis for system-level defects and field issues. Ensuring traceability between requirements, risks, test cases, and verification evidence. Driving continuous improvement of system test methodologies, automation strategies, and test infrastructure. Supporting regulatory submissions and audits by providing complete and audit-ready test documentation. Ensuring compliance with applicable medical device standards and regulations throughout testing activities. To succeed in this role, you should have the following skills and experience: Bachelor's or Master's degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Systems Engineering, or a related technical field. Minimum of 15 years of experience leading testing teams in a medical device environment. Strong experience in system verification and validation for complex medical device systems. Proven experience supporting both New Product Introduction (NPI) and sustaining engineering activities. Deep understanding of medical device development processes, including verification, validation, risk management, and traceability. Proven experience collaborating with regulatory agencies and external accredited test laboratories to support compliance testing, certification activities, and successful regulatory submissions. Strong knowledge of IEC 60601-1 and IEC 60601-1-2 standards. Familiarity with IEC 60601-2-34 and IEC 60601-2-37 standards is considered a strong plus. Experience with system integration testing, regression testing, and reliability testing. Experience supporting complaint investigations, CAPA, and post-market surveillance activities. Strong analytical, troubleshooting, and root cause analysis skills. Experience working with cross-functional and global teams, including external suppliers and contract manufacturers. Proven track record in creating audit-ready documentation and supporting regulatory submissions. Familiarity with requirements and test management tools (e.g., DOORS, DNG, Windchill, Jira, test automation frameworks). Excellent communication and leadership skills, with the ability to influence technical decisions across organizations. A proactive mindset, strong ownership mentality, and passion for delivering safe and reliable medical devices. Position Details: Due to the increasing complexity and volume of sustaining activities, combined with the upcoming integration of Avila Flight 3 and Trinity, the need for a highly experienced Lead System Test Engineer has become critical to the success of the organization. This role will provide strong technical leadership, strategic direction, and increased execution capacity for the San Diego System Test team. By adding this resource, we will strengthen our ability to successfully deliver on both our NPI and Sustaining commitments. . Additional Details Minimum required qualifications : Minimum required Education: Bachelor's / Master's Degree in Electrical Engineering, Electronic Engineering, Mechanical Engineering, Computer Science Engineering or equivalent. Minimum required Experience: Minimum 5 years of experience with Bachelor's OR Minimum 3 years of experience with Master's in areas such as System Architecture, System Design, Hardware Engineering or equivalent.

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