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The Senior Validation Engineer is responsible for ensuring that complex hardware, software, or mixed-signal systems meet all performance, reliability, and safety requirements before release. This role leads the planning, execution and documentation of verification and validation activities, working closely with cross-functional teams to define test strategies, evaluate system behavior and drive issue resolution. You will also develop automated and manual test methods, analyze data to verify compliance with specifications and ensure full traceability to requirements and regulatory standards. The Validation Engineer will also heavily contribute to the design of medical implants and systems.
Job Responsibility:
Lead the creation of validation plans, test strategies, and acceptance criteria based on system requirements, design architecture, and regulatory expectations
Develop and execute detailed test protocols to evaluate hardware, software, and mixed-signal system performance under a variety of operating and environmental conditions
Build automated and manual test setups using laboratory equipment, data-acquisition tools, scripting languages, and custom fixtures as needed
Analyze test results, perform statistical evaluations, and generate clear documentation of findings, including deviations, failures, and recommendations for corrective actions
Identify root causes of system issues by collaborating with design, firmware, software, and manufacturing teams, and drive resolution through structured problem-solving methods
Maintain full traceability between requirements, test coverage, and validation outcomes using appropriate tools and documentation standards
Ensure test methods and documentation comply with applicable quality-system, safety, and regulatory requirements (e.g., ISO, FDA, IEC, GAMP)
Support system bring-up, design-for-testability reviews, and transitions from development to manufacturing or production test environments
Provide mentorship to junior engineers and contribute to continuous improvement of validation processes, tools, and methodologies
Requirements:
M.S. in Electrical Engineering
8+ years experience
Solid understanding of industry standards and regulatory frameworks such as FDA QSR, ISO13485, IEC 60601, ISO 14971, or GAMP 5, depending on the application domain
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