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.
