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Senior Validation Engineer

Blackrock Neurotech

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Location:
United States, Salt Lake City

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Category:
Research and Development

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

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
  • Ability to work in office setting

Additional Information:

Job Posted:
December 06, 2025

Work Type:
On-site work
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