Manufacturing Engineer II
Medacta USA, Inc.
Manufacturing Engineer II
The Manufacturing Engineer II will support the development, optimization, and continuous improvement of manufacturing processes to achieve production goals within precision machining operations, including Swiss-style CNC machining and vertical milling, while also supporting prototype development activities. Strong technical expertise in CNC programming, CAD/CAM systems, process development, and cross-functional collaboration with Research & Development (R&D), Quality, and Operations teams is essential.
The Manufacturing Engineer II will:
- Develop, optimize, validate, and maintain manufacturing processes for precision medical device components used in sports medicine applications.
- Program, set up, troubleshoot, and support Swiss-style CNC machines and vertical milling equipment.
- Create and optimize CNC programs to improve cycle time, quality, tooling performance, and overall manufacturing efficiency.
- Collaborate closely with R&D teams to develop and manufacture prototypes, fixtures, and proof-of-concept components during new product development.
- Utilize CAD/CAM software to design tooling, fixtures, workholding, and manufacturing solutions.
- Generate and maintain manufacturing documentation including work instructions, process flows, setup sheets, validation protocols, tooling documentation, and engineering change documentation.
- Support Design for Manufacturability (DFM) initiatives during product development and design reviews.
- Participate in process validations including IQ/OQ/PQ activities in accordance with medical device quality requirements.
- Coordinate project activities and provide regular status updates using project management and collaboration tools such as Wrike or similar platforms.
- Assist in equipment selection, tooling evaluation, and capital improvement projects as needed.
- Ensure compliance with company policies, FDA regulations, ISO standards, and applicable safety requirements.
- Performs other related duties as assigned.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this position. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.
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