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 studying product requirements; researching, designing, modifying, and testing manufacturing methods and equipment; conferring with equipment vendors and customers.
• Keeps equipment operational by coordinating maintenance and repair services; following manufacturer's instructions and established procedures; requesting special service; training the maintenance staff.
• 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.
• Provide written protocols, reports, and engineering documentation as necessary
• 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
• Manage automation equipment projects to ensure equipment design concept challenges are successful and milestone dates are met.
• Provide FAT leadership at equipment vendor locations. Work directly with equipment vendor and internal team to ensure equipment meets all specifications, documenting URS or performance gaps and managing vendors contingency plans, to resolve before acceptance of equipment.
• Manage equipment installation at production facility.
• 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.
• Create documentation for production operators, maintenance technicians, and calibration departments to be able to operate and maintain equipment.
• 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
• Basic computer skills in MS Word, Excel and Project
• Understanding of GAMP methodology, ability to compose and execute FAT, SAT, IQ/OQ, and PQ validation phases