Job Title: Lead System Tester
Location: San Diego, California (Hybrid)
Job Summary: We are seeking an individual to provide leadership and strategic direction for a multidisciplinary team focused on verification and validation of advanced medical device platforms. Our team is responsible for ensuring the performance, safety, and regulatory compliance of innovative clinical imaging solutions throughout the product lifecycle.
Responsibilities:
- Lead system-level verification and validation activities for both New Product Introduction (NPI) and sustaining projects, ensuring alignment with product and regulatory requirements.
- Define and execute comprehensive system test strategies, plans, protocols, and reports while driving continuous improvement of test methodologies and infrastructure.
- Guide multidisciplinary testing teams in functional, integration, regression, reliability, and compliance testing, both internally and with external test houses.
- Collaborate cross-functionally with engineering, quality, regulatory, manufacturing, and external suppliers to support test coverage, root cause investigations, and regulatory submissions.
Required:
- 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 within a medical device environment, with proven experience in system verification and validation for complex systems.
- Demonstrated expertise in medical device development processes, including verification, validation, risk management, and traceability, with strong knowledge of IEC 60601-1 and IEC 60601-1-2 standards.
- Experience collaborating with regulatory agencies and accredited laboratories, supporting compliance testing, certification, regulatory submissions, and audit-ready documentation.
About SSI People: With over 26 years of industry experience, SSi People has built its reputation and expertise on putting people first. Everything we do works toward delivering exceptional experience for our consultants, our clients, and our internal team. Through a genuine commitment to people in everything we do. We have developed refined processes and a stellar internal team to deliver talent quickly. More importantly, we focus on building long-term relationships, not transactions. Putting people first is just what we do well.
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