Engineer Verification & Validation

Medline•Mundelein, IL

About The Position

Under general supervision, the Engineer Verification & Validation plans and executes verification and validation activities to ensure regulatory compliance. The role inspects, measures, analyzes, audits, calibrates, and tests instrumentation, equipment, software and hardware, machines, and procedures. It identifies problems and their sources and addresses them efficiently, implements process improvements, and identifies product improvement opportunities. The engineer creates and documents an evidence trail showing that testing procedures and protocols are accurate and comply with regulatory requirements. The position tests and evaluates products of moderate to advanced complexity, interprets data to verify product requirements and design inputs, and executes or helps develop verification and validation protocols. It produces reports for regulatory audits, submissions, and requests, and maintains thorough documentation throughout the verification and validation lifecycle. The role also analyzes results, contributes to design and failure investigations, identifies root causes and risks, supports test-method development, collaborates with design and development teams on product requirements, and manages assigned projects and timelines.

Requirements

  • Bachelor’s degree in Engineering or equivalent knowledge.
  • At least 2 years of experience with verification or validation testing.
  • Experience analyzing and reporting data to identify issues, trends, or exceptions.
  • Experience evaluating information to determine compliance with standards, laws, and regulations.

Responsibilities

  • Test and evaluate new and existing products of moderate to advanced complexity.
  • Interpret data and evaluate product performance to verify product requirements and design inputs.
  • Execute and assist with the development of verification and validation protocols.
  • Issue reports for regulatory audits, submissions, and requests.
  • Create thorough documentation recording the steps taken and measurements used throughout the verification and validation lifecycle.
  • Analyze test results and contribute to design and failure investigations.
  • Determine root causes of defects, safety risks, and performance problems.
  • Use data to provide risk assessments, identify mitigating factors, and check adherence to regulatory standards.
  • Assist with test-method development, including test fixture design, equipment acquisition, and hardware/software validation.
  • Collaborate with design and development teams to develop product requirements based on user needs, regulatory strategy, and applicable standards.
  • Manage assigned projects, establish timelines, and ensure deadlines and project goals are met.
  • Identify problems and their sources and correct them efficiently.
  • Implement process improvement initiatives and identify product improvement opportunities.

Benefits

  • Competitive total rewards package.
  • Continuing education and training.
  • Health insurance.
  • Life and disability benefits.
  • 401(k) contributions.
  • Paid time off.
  • Employee Assistance Program, Employee Resource Groups, and Employee Service Corp for employees working less than 30 hours per week on average.
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