The position of Manufacturing Engineer is responsible for the creation and implementation of manufacturing processes for production of Medical Devices. This position will oversee the various manufacturing processes in order to meet regulatory compliance, production efficiencies, quality, and reliability objectives. The position will provide engineering support for new product development, with the objective to transition products into production.
• Create, develop, and maintain written instructions for manufacturing processes
• Develop and implement process controls for manufacturing to ensure repeatability, reliability, and quality of products & processes
• Provide training to production personnel on manufacturing processes
• Design, develop, and perform verification/validation testing as it relates to manufacturing processes, equipment, assembly fixtures, etc.
• Work with Research and Development in the transition of products into production
• Research, source, and design equipment as it relates to the manufacturing process
• Work with various groups within the organization on CAPA related projects
• Work with various groups within the organization on complaint investigations
• Ensure manufacturing processes are in conformance with ISO and FDA guidelines
• Participate in service trend analysis for regulatory compliance
• Minimum of 10 years experience as an engineer in a Medical Device manufacturing environment.
• Bachelor’s degree in a technical field required; Mechanical, Electrical, or Industrial engineering preferred.
• The individual should possess a wide range of engineering, design, and computer skills in support of manufacturing operations.
• Possess knowledge and proven experience in an ISO and/or FDA environment.
• Possess leadership skills to teach, train, and lead others in the manufacturing process.