Manufacturing Engineer II

Medacta USA, Inc.•Sarasota, FL

25d•Onsite

About The Position

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.

Requirements

Bachelor’s Degree in Manufacturing Engineering, Mechanical Engineering or Biomechanical Engineering or equivalent technical degree.
Minimum 5-7 years of manufacturing engineering experience within a precision machining or medical device manufacturing environment.
Strong hands-on experience with Swiss-style CNC machining and programming
Strong hands-on experience with Vertical CNC milling operations
Strong hands-on experience with Precision machining processes and tooling
Proficiency with CAD/CAM software systems.
Experience reading and interpreting engineering drawings, GD&T, and technical specifications.
Demonstrated ability to troubleshoot machining and process-related issues.
Experience supporting prototype development and new product introduction (NPI) activities.
Strong project coordination and communication skills.
Experience using project management or collaboration software such as Wrike, Microsoft Project, or similar systems.
Excellent written and oral communication skills.

Responsibilities

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, 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.