Sr Manufacturing Engineer

CAIREBall Ground, GA
Onsite

About The Position

The Senior Manufacturing Engineer at CAIRE will lead the optimization of manufacturing processes, ensuring the highest quality, efficiency, and safety standards. This role will focus on improving production workflows, troubleshooting technical issues, and implementing lean manufacturing techniques. The Senior Manufacturing Engineer will collaborate with cross-functional teams to drive continuous improvement, streamline operations, and support the development of innovative products.

Requirements

  • Bachelor’s Degree in Manufacturing Engineering, Mechanical Engineering, Biomedical Engineering, or a related field
  • 5-10 years of experience in manufacturing engineering, preferably in the medical device or healthcare industry.
  • Strong experience with manufacturing processes, such as CNC machining, injection molding, assembly and/or automation.
  • Experience with regulatory standards such as FDA (21 CFR Part 820), ISO 13485, and Good Manufacturing Practices (GMP).
  • Proven track record of process optimization, cost management, and quality improvement.
  • Experience in leading cross-functional teams and collaborating with R&D, quality, and supply chain departments.
  • Familiarity with CAD software (e.g., SolidWorks, AutoCAD) for designing or modifying production equipment and tools.
  • Hands-on experience with root cause analysis and problem-solving techniques (e.g., Six Sigma, Lean).

Nice To Haves

  • Master’s Degree in Engineering or Business Administration

Responsibilities

  • Improve manufacturing processes for efficiency, cost-effectiveness, and product quality.
  • Ensure adherence to industry regulations (e.g., FDA, ISO 13485).
  • Work with R&D, quality, and supply chain teams to streamline production.
  • Solve complex manufacturing issues and lead root cause analysis.
  • Mentor and guide junior engineers and production staff.
  • Develop and maintain budget controls while ensuring quality standards.
  • Implement automation and advanced manufacturing technologies.
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