Sr Engineer Verification & Validation

Medline • Mundelein, IL

19h

About The Position

Under limited supervision, lead verification and validation activities to ensure regulatory compliance. Inspect, measure, analyze, audit, calibrate, and test instrumentation, equipment, software and hardware, machines, and procedures. Identify and efficiently correct problems and their sources, implement process improvements, and identify product improvement opportunities. Create and document evidence that testing procedures and protocols are accurate and meet regulatory requirements.

Develop, author, and execute verification and validation protocols; prepare reports for regulatory audits, submissions, and requests; and maintain thorough documentation throughout the verification and validation lifecycle. Analyze test results and contribute to design and failure investigations, root-cause analysis, risk assessment, and evaluation of regulatory compliance.

Lead test-method development, including test-fixture design, equipment acquisition, and hardware and software validation. Apply technical knowledge of device design and core technologies to develop test methods, interpret data, and evaluate product performance against requirements and design inputs. Collaborate with design and development teams on product requirements informed by user needs, regulatory strategy, and applicable standards. Lead laboratory process improvement, regulatory investigations, and data trending; research and recommend equipment and methods and conduct required qualifications. Mentor engineers, lead small project teams, and provide guidance on design controls and laboratory practices and procedures.

Medline Industries, LP, and its subsidiaries offer a competitive total rewards package, continuing education and training, and career potential in a growing worldwide organization. The anticipated annual salary range is $92,000–$138,000; actual compensation varies based on location, education, experience, skills, and abilities. The role is bonus and/or incentive eligible. Benefits for employees working an average of 30 or more hours per week include health insurance, life and disability coverage, 401(k) contributions, and paid time off. The company also describes benefits for employees working fewer than 30 hours per week. Medline is an equal opportunity employer committed to belonging, diversity, and inclusion.

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.

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 thorough documentation recording steps and measurements 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; assess risks, identify mitigating factors, and check compliance with regulatory standards.
• Lead test-method development, including test-fixture design, equipment acquisition, and hardware/software validation.
• Apply technical expertise in device design and core technologies to test-method development, data interpretation, and product-performance evaluation against requirements and design inputs.
• Collaborate with design and development teams to develop product requirements based on user needs, regulatory strategy, and applicable standards.
• Lead laboratory process improvement, regulatory investigations, and data trending.
• Research and recommend new equipment and methods and perform necessary qualifications.
• Mentor lower-level engineers, lead small project teams, and ensure metrics and timelines are met.
• Guide other engineers on design controls and laboratory practices and procedures.

Benefits

• Health insurance
• Life and disability coverage
• 401(k) contributions
• Paid time off
• Continuing education and training
• Employee Assistance Program access (for employees working fewer than 30 hours per week)
• Employee Resource Groups (for employees working fewer than 30 hours per week)
• Employee Service Corp access (for employees working fewer than 30 hours per week)
• Bonus and/or incentive eligibility

What This Job Offers

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