Engineer

• Define innovative and high valued products for the business
• Create and develop novel concepts and designs
• Lead the verification and validation testing of these designs
• Fully transfer new devices to manufacturing
• Support the efficient, high-quality design and development of medical device systems
• Work cross-functionally with manufacturing, project management, R&D, procurement, regulatory, marketing, quality, and operations team members, as well as external suppliers
• Develop packaging specifications and associated engineering documents
• Develop packaging testing methods
• Perform, or direct test method validations and train others to use these methods as required
• Perform validation of new or modified packaging designs to appropriate and current regulatory standards
• Work directly with outside suppliers to develop optimal package designs and/or components
• Coordinate and communicate packaging technology and designs with project teams and management staff as part of project management and design control activities
• Identify, review, and evaluate new packaging technology for application to current and future product designs
• Participate in development of risk analysis associated with packaging design and associated processes
• Document all packaging and labeling design, development, and testing to comply with FDA design control regulations and industry standards for sterile barrier packaging systems and processes
• Identify and assess new medical packaging material and perform selection and analysis
• Maintain and improve product quality by performing and documenting robust root cause investigations and implementing effective corrective and preventive actions as part of the CAPA process.
• Improve R&D packaging procedures to improve time-to-market, test lab bandwidth, and lower R&D packaging costs.
• Stay current with worldwide packaging regulations.
• Resolve R&D packaging compliance gaps through thorough testing and/or procedure gaps.

R&D Packaging Engineer III

Principal Substation Engineer

Roadway Transportation Engineer

Machine Learning Engineer

Endpoint Engineer

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