Packaging Verification & Validation Engineer at Medline Industries, Inc. in Mundelein, Illinois

Job Description:

Job Summary

Under general supervision, plan and execute verification and validation activities related to medical device product packaging.
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 medical device product testingare accurate and follow regulatory requirements.

Job Description

MAJOR RESPONSIBILITIES

• Test and evaluate new and existing products of moderate to advanced complexity.


• Interpret data and evaluate productperformance to verify product packaging requirements and design inputs.


• Execute and assist with the development of verification and validation protocols for medical device product packaging.


• 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.


• Assist with test method development activities including test fixture design, equipment acquisition, and hardware/software validation.


• Test method development activities will include a focus on device packaging methods related to sterility, seal strength, and material level properties per ISO 11607-01.


• Collaborate with design and development teams to develop product requirements based on user needs, regulatory strategy, and applicable standards.


• Manage assigned projects, establish appropriate timelines, and ensure that deadlines/project goals are met.

Education:

• Bachelor’s Degree in Engineering or equivalent knowledge.

Work Experience:

• At least 2 years with verification or validation testing. Knowledge / Skills / Abilities: Experience analyzing and reporting data in order to identify issues, trends, or exceptions.


• Experience evaluating information to determine compliance with standards, laws, and regulations.

Benefits - Medline is committed to offering competitive benefits and a variety of choices to best meet the needs of you and your family. For employees scheduled to work at least 30 hours per week, this includes health and well-being, financial fitness, career development, paid time off and more. Employees scheduled to work less than 30 hours per week can participate in the 401(k) plan, access the Employee Assistance Program (EAP), Employee Resource Groups (ERG) and Medline Service Corps. For a more comprehensive list of our benefits, please click here.

Every day, we’re focused on building a more diverse and inclusive company, one that recognizes, values and respects the differences we all bring to the workplace. From doing what’s right to delivering business results, together, we’re better. Explore our Diversity, Equity and Inclusion page here.

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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