Manufacturing Engineer

Description

• Evaluates manufacturing processes by designing and conducting research programs; applying knowledge of product design, fabrication, assembly, tooling, and materials; conferring with equipment vendors and or customers; soliciting observations from operators.
• Develops manufacturing processes by designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors and customers.
• Assures product and process quality by designing testing methods; testing finished- product and process capabilities; establishing standards; confirming manufacturing processes.
• Designing new equipment and processes for the introduction of new products or for the improvement of existing ones; conferring with equipment vendors and customers.
• Present and communicate technical and project-related information effectively inside and outside the organization
• Facilitate and participate in equipment design reviews with a cross-functional team of persons from Engineering, Automation, and Maintenance to ensure best attributes are included in equipment concepts
• Create documentation for production operators, maintenance technicians, and calibration departments to be able to operate and maintain equipment.
• Support equipment during production launch to ensure production metrics are met.
• Work with manufacturing facility engineering & management to identify opportunities for existing automation to reduce cost and improve quality, with a focus on flexible automation that can be used across multiple customer programs.
• Work with manufacturing facility engineering & management to identify opportunities for existing automation to reduce cost and improve quality, with a focus on flexible automation that can be used across multiple customer programs.

• Bachelor degree in mechanical engineering, electrical engineering, manufacturing engineering, industrial technology, or equivalent mix or education and experience
• Minimum 5 years proven experience in development of automated systems(automation or manufacturing engineer)
• Experience with medical device manufacturing and working in cleanroom environments
• Experience with SolidWorks or other mechanical CAD system
• Understanding of GAMP methodology, ability to compose and execute FAT, SAT, IQ/OQ, and PQ validation phases