Process/Design Engineer

Summary:
A Process/Design Engineer is responsible for all technical and engineering aspects of their assigned projects. They plan, schedule, predict and manage all tasks of their assigned project within the frame work of ISO/FDA and Epimed’s guidelines to assure accuracy, proper resources and quality from start to finish. Designs and implements systems and equipment procedures used in Epimed’s manufacturing facilities, including testing and monitoring equipment, updating current system processes and conducting risk assessments.
Essential Duties and Responsibilities: (others may be assigned)
• Assist in the overall design and technical effort needed to support the sale, engineering, and production of medical products
• Technical leader responsible for providing process design, equipment, documentation, and operating instructions for new and repeat manufacturing processes
• Apply continuous improvement methods such as lean manufacturing methodology to enhance quality, reliability, or cost-effectiveness
• Ensures that all work is performed in accordance with standard operating procedures (SOPs), current Good Manufacturing Practices (cGMP), safety procedures, and quality standards
• Fundamental understanding of process instrumentation and automation
• Incorporate new methods and processes to improve existing operations.
• Provide technical leadership for the manufacturing processes to resolve operational problems as it relates to producibility, conformance to the drawing or specifications, material use and bottlenecks in the process.
• Develop detailed manufacturing drawings
• Develop and perform IQ, OQ, and PQ protocols
• Collaborate with Manufacturing, Regulatory, and Quality Operations to control and reduce production variances
• Interact regularly with consulting engineers, contractors, and/or government entities to develop acquire approvals for manufacturing drawings
• < 10% travel required Salary $60,000 - $90,000