Sr. Packaging Verification & Validation Engineer-

Mundelein, Illinois

Employer: Medline Industries
Industry: Quality/Regulatory/R&D
Salary: Competitive
Job type: Full-Time
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 medical device packaging. Proven ability to design packaging and packaging components to meet specifications within project timelines


PREFERRED KNOWLEDGE / SKILLS / ABILITIES

  • 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.
Created: 2024-05-18
Reference: QUA0101VV
Country: United States
State: Illinois
City: Mundelein

Similar jobs: