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Position Title: Manufacturing Engineer II                                                            FLSA Status: Salary - Exempt            Department: Operations                                                                                        Location: Sarasota, Florida

Supervisor: Director, Site and Production                                                                                                                      

Medacta is a Swiss-based orthopedic company founded in 1999, renowned for its innovative products and surgical techniques. Notably, they pioneered the Anterior Minimally Invasive Surgery (AMIS) technique for hip replacements, MyKA Kinematic Alignment Platform for knee replacement, and NextAR Augmented Reality Surgical Platform for use in shoulder, spine, and knee procedures. Leveraging their extensive orthopedic expertise, Medacta introduced MySolutions technology, which provides surgeons with highly personalized pre-operative planning and implant placement methodologies. Utilizing advanced personalized kinematic models and 3D planning tools, MySolutions enhances surgical precision in hip, knee, shoulder, and spine procedures. Medacta's blend of orthopedic expertise and cutting-edge technology drives continual advancements in the field, enhancing patient care worldwide.

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.

Educational Requirements:

Bachelor's Degree in Manufacturing Engineering, Mechanical Engineering or Biomechanical Engineering or equivalent technical degree.

Experience Requirements:          

Minimum 5-7 years of manufacturing engineering experience within a precision machining or medical device manufacturing environment.

Required Skills and Abilities:

• Strong hands-on experience with:
  • Swiss-style CNC machining and programming
  • Vertical CNC milling operations
  • 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.
• Physical Requirements:
  • Sitting: Extended periods at a desk or workstation.
  • Standing and Walking: Occasional movement within the office and manufacturing facility.
  • Lifting and Carrying: Light to moderate lifting of office materials and raw material stock.
  • Manufacturing Floor s: Standing for prolonged periods, as well as lifting and moving tooling and bar stock up to 30 pounds each.

Additional tasks may require reaching, manual dexterity, and visual acuity.

External: Surgeons during facility tours and suppliers of capital equipment and tooling.

Internal: Manufacturing, Planning, Purchasing,  Finance, Compliance, Quality, Regulatory, Human Resources, and Medacta International Personnel.

Travel requirements: Travel of up to 5% may be required. 

Extent of Confidential Information: Highly confidential information regarding engineering drawings, GD&T and technical specifications.

• 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.

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.