Senior Verification & Validation Engineer - Mundelein, IL

Medline • Mundelein, IL

8d • Onsite

About The Position

Under limited supervision, lead verification and validation activities. Ensure regulatory compliance by inspecting, measuring, analyzing, auditing, calibrating and testing instrumentation, equipment, software/hardware, machines and/or procedures. Identify problems and their sources and correct them quickly and efficiently. Implement process improvement initiatives and identify product improvement opportunities. Create and document an evidence trail to show that the procedures and protocols used during testing are accurate and follow regulatory requirements.

Requirements

• At least 4 years with verification or validation testing.
• Experience analyzing and reporting data in order to identify issues, trends, or exceptions.
• Experience evaluating information to determine compliance with standards, laws, and regulations.

Nice To Haves

• 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.

Benefits

• health insurance
• life and disability
• 401(k) contributions
• paid time off
• Employee Assistance Program
• Employee Resource Groups
• Employee Service Corp

What This Job Offers

• Job Type: Full-time
• Career Level: Senior