Senior Verification & Validation Engineer - Mundelein, IL

About the Role

Under limited supervision, lead verification and validation activities to ensure regulatory compliance. Responsibilities include inspecting, measuring, analyzing, auditing, calibrating, and testing instrumentation, equipment, software/hardware, machines, and procedures. Identify and correct problems, implement process improvements, and identify product improvement opportunities while creating and documenting an evidence trail for regulatory requirements.

Responsibilities

• Develop, author, and execute verification and validation protocols.
• Issue reports for regulatory audits, submissions, and requests.
• Create accurate and thorough documentation recording all steps and measurements in 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, providing risk assessments and identifying mitigating factors.
• Lead test method development activities, including test fixture design, equipment acquisition, and hardware/software validation.
• Provide technical expertise to inform test method development, data interpretation, and evaluation of product performance.
• 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.

Requirements

• Bachelor’s Degree in Engineering or equivalent knowledge.
• At least 4 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.

Preferred Qualifications

• Experience interacting with regulatory auditors.
• Experience with design controls, risk assessment, and root cause analysis.
• Experience with process improvement and project management.

Benefits

• Competitive total rewards package.
• Continuing education and training.
• Health insurance, life and disability coverage.
• 401(k) contributions.
• Paid time off.
• Employee Assistance Program, Employee Resource Groups, and Employee Service Corp (for roles with less than 30 hours per week).

Pay

The anticipated salary range for this position is $92,000.00 - $138,000.00 annually. The actual salary will vary based on applicant’s location, education, experience, skills, and abilities. This role is bonus and/or incentive eligible.