Lead Verification & Validation Engineer (Regulatory)

Regulatory Jobs; Mundelein (IL); On-site; USD 92,000 - 138,000; Full time

Benefits offered by this job

Health insurance

401(k) contributions

Paid time off

Job summary

Medline Industries, LP in the United States is seeking an experienced Verification and Validation professional to lead regulatory compliance activities, inspecting and testing instrumentation, and documenting evidence trails to ensure procedures and protocols comply with regulatory requirements.

You will develop verification and validation protocols, analyze results, and lead design and failure investigations.

Qualifications

• Bachelor's Degree in Engineering or equivalent knowledge.
• At least 4 years with verification or validation testing.
• Experience analyzing data to identify issues, trends, or exceptions.
• Experience evaluating information to determine compliance with standards, laws, and regulations.

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

Data analysis

Regulatory compliance

Education

Bachelor's Degree in Engineering

Job description

Medline Industries, LP in the United States is seeking an experienced Verification and Validation professional to lead regulatory compliance activities, inspecting and testing instrumentation, and documenting evidence trails to ensure procedures and protocols comply with regulatory requirements.

You will develop verification and validation protocols, analyze results, and lead design and failure investigations.