Qualification Required

• BS Degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related field required.

Roles And Responsibilities

The Manufacturing Engineer will play a key role in supporting existing processes for the casting of medical device components.

• Conducts and directs minor sections of new manufacturing process development projects and assists in performing more complex engineering projects to evaluate, select, and adapt standard manufacturing techniques, procedures, and criteria to increase the efficiency of plant operations.
• Analyzes new processes, technologies, and equipment with the intent of achieving continuous improvement of present methods using process cost evaluation, quality and capability alternatives analyses, and process characterization.
• Assignments usually include one or more of the following: equipment design and development, the test of materials, preparation of specifications, process study, research investigations, and report preparation.
• Provides process engineering support of existing processes and supports activities related to the development of new processes including researching the current and emerging technologies, and evaluating process cost, quality, and capability alternatives.
• Works in a manufacturing environment in compliance with the Quality System Regulation (QSR), Standard Operating Procedures (SOP), and applicable Work Instructions.
• Provides day-to-day support to a limited number of types of operations as e.g. but not limited to turning, milling, drilling, EDM, finishing, packaging, etc. as required in support of the assigned area.
• Studies operations sequence, material flow, functional statements, organization charts, and project information to determine worker functions and responsibilities.
• Identifies and assists in instituting state-of-the-art new and innovative manufacturing technologies as well as process improvements for existing manufacturing processes utilizing appropriate engineering principles and standard strategies e.g. Lean and 5S principles.
• Helps develop project schedules and assists in tracking costs, preparing status reports, conducting meetings, documenting, and communicating progress to management.
• Performs process tests along with associated inspection, process control, documentation, and data collection activities.
• Assists in developing fixturing and tooling design concepts and has the ability to express and implement ideas with tool designers.
• Supports new equipment acquisition efforts including machine selection, installation, validation, employee training, and other related equipment responsibilities as required.
• Assists Quality Engineers in gage design, gage R&R, and implementation.
• Assists in the development of SOPs, other control processes, and practices as it pertains to a certain defined cell or area.
• Interfaces regularly with other Manufacturing Engineers, Manufacturing and Engineering Supervisors, QA Inspectors, and Product Development Engineers.
• Acts as a liaison to vendors with regard to contracted products, tools & fixtures, and their manufacture.

Required Technical And Professional Expertise:

EU-MDR, CNC programming, Quality System Requirements (QSR), Manufacturing Materials, Lean Manufacturing, Six Sigma, inventory optimization, Production NC, CAPA, Regulatory Requirements, Verification & Validation, Medical devices Engineering change process, Medical Devices Quality Management, Design controls, problem solving skills, etc.