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Responsibilities:

• Evaluation of production equipment
• Production support and process validation
• Interface with vendors for incoming components
• Troubleshoot manufacturing process and equipment
• Protocol and report writing
• Execution of IQ/OQ/PQs, Test Method Validation and PPQs
• Generate and modify manufacturing process documentation
• Work with cross functional teams as required
• Develop and implement process improvements
• Resolve and/or facilitate resolution of problems including identifying causes to prevent re-occurrence
• Establish processes based on product and print specifications
• Evaluate process and design alternatives based on "design for manufacturability" principles
• Understands principles of "Cost of Goods Sold"
• Manage program compliance with "Quality Control" requirements (i.e. Design Control, Process validation etc.).

Requirements:

• 0 4 years engineering experience
• Experience designing and testing medical devices preferred
• Experience developing manufacturing processes and technologies and designing for manufacturability preferred
• Experience working in a broader enterprise/cross-division business unit model preferred
• Experience with molding, catheter shaft construction/bonding, or coating processes preferred