Lead Verification & Validation Engineer, Regulatory Compliance

Medline Industries, Inc.; Mundelein (IL); On-site; USD 92,000 - 138,000; Full time

Job summary

Medline Industries, LP is seeking an experienced verification and validation specialist to lead testing activities, ensure regulatory compliance, and document evidence trails across instrumentation and software.

You will develop protocols, analyze results, investigate root causes, collaborate with design teams, and mentor junior engineers while contributing to process improvements. The role offers a competitive salary and comprehensive benefits.

Qualifications

• Bachelor’s degree in Engineering or equivalent knowledge.
• At least 4 years of verification or validation testing experience.
• Experience analyzing data to identify issues, trends, or exceptions.
• Experience evaluating information to determine compliance with standards, laws, and regulations.
• Experience interacting with regulatory auditors.
• Experience with design controls, risk assessment, and root cause analysis.
• Experience with process improvement and project management.

Responsibilities

• Develop, author, and execute verification and validation protocols. Issue reports for regulatory audits, submissions and requests.
• Create accurate and thorough documentation that records all steps taken and all measurements used through the verification and validation lifecycle.
• Analyze test results and contribute to design and failure investigations. Determine the root cause of defects, safety risks, and performance problems. Use the data to provide a risk assessment, identify mitigating factors and check for adherence to regulatory standards.
• Lead test method development activities including test fixture design, equipment acquisition, and hardware/software validation.
• Provide technical expertise by understanding device design and core technologies to inform test method development, data interpretation, and evaluation of product performance to verify product requirements and design inputs.
• Collaborate with design and development teams to develop product requirements based on user needs, regulatory strategy, and applicable standards.
• Lead process improvement, regulatory investigations, and data trending activities within the laboratory. Research and recommend new equipment/methods and perform necessary qualifications.
• Mentor lower level engineers, lead small project teams and ensure metrics/timelines are met. Provide guidance to other engineers on design controls and test lab practices and procedures.

Skills

Verification & validation

Regulatory compliance

Data analysis

Regulatory audits liaison

Process improvement

Education

Bachelor’s degree in Engineering

Job description

Medline Industries, LP is seeking an experienced verification and validation specialist to lead testing activities, ensure regulatory compliance, and document evidence trails across instrumentation and software.

You will develop protocols, analyze results, investigate root causes, collaborate with design teams, and mentor junior engineers while contributing to process improvements. The role offers a competitive salary and comprehensive benefits.