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

Job Description:

JOB SUMMARY:

• Under limited supervision, lead 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.


• Primary Contact for DOT Packaging Laboratory and collaboration with project teams on new product development.


• 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 packaging testing are accurate and follow regulatory requirements.

• Develop, author, and execute verification and validation protocols related to 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 of medical device packaging configurations.


• Analyze test results and contribute to device packaging 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. 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.


• 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 medical device packaging product requirements based on user needs, regulatory strategy, and applicable standards.


• Lead process improvement, regulatory investigations, and data trending activities within the DOT Packaging 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.

EDUCATION

• Bachelor's Degree in Engineering or equivalent knowledge.

• 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.
• Experience investigating and owning device packaging nonconformances and CAPA

• Experience interacting with regulatory auditors.
• Experience with process improvement and project management.
• Experience with IQ/OQ/PQ equipment qualifications for packaging test equipment.
• Equipment in scope includes but is not limited to vibration table, drop tester, compression tester, and environmental chambers.
• Experience with Test Method Validation strategies such as Gage R&R and Attribute Agreement Analysis.
• Demonstrated experience in designing, developing, and qualifying medical device packaging. Proven ability to design packaging and packaging components to meet specifications within project timelines

• Effective communication of technical knowledge of packaging test methods, standards, and equipment.
• Knowledge of the following standards: ISO 11607-01, ISO 11607-02, ISO 16775, ISO 13485, ISO 14971, EU MDR, ASTM D4169, ASTM D7386, ISTA 3A, UDI.