at Medline Industries, Inc. in Mundelein, Illinois, United States
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.
MAJOR RESPONSIBILITIES:
- 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.
WORK EXPERIENCE
- At least 4 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.
- Experience investigating and owning device packaging nonconformances and CAPA
PREFERRED JOB REQUIREMENTS
- 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...
Equal Opportunity Employer - minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity
