What are the responsibilities and job description for the Lead System Tester position at SSi People?
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
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from SSi People and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: SSi People Privacy Policy
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.
- 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.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from SSi People and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: SSi People Privacy Policy