Manufacturing Engineer

Manufacturing Engineer (Medical Device Manufacturing, Process Engineering, Continuous Improvement)

About the Role:
This Manufacturing Engineer position offers the opportunity to play a key role in the production of advanced medical devices and precision-engineered components. The role focuses on optimizing manufacturing processes, enhancing production efficiency, and ensuring product quality in a regulated environment. The Manufacturing Engineer will collaborate across engineering, operations, and quality teams to develop, implement, and continuously improve processes that meet industry standards and safety requirements.

Responsibilities:

• Design, implement, and optimize manufacturing processes to improve efficiency, quality, and safety.

• Develop and validate automated and manual production systems to ensure repeatable and compliant outcomes.

• Evaluate manufacturing performance using metrics such as throughput, yield, and cost efficiency.

• Provide accurate cost estimates for new and existing projects, supporting pricing and resource planning.

• Plan and improve factory layouts, material flow, and equipment utilization for optimal productivity.

• Collaborate with cross-functional teams to troubleshoot issues, resolve production bottlenecks, and reduce waste.

• Train operators and technicians on new equipment, tooling, and process updates.

• Maintain compliance with ISO, FDA, and environmental health and safety standards.

• Research and recommend new technologies to advance manufacturing capabilities.

• Lead or assist with continuous improvement initiatives and lean manufacturing projects.

Qualifications:

• Minimum of 5 years of experience as a Manufacturing Engineer or in a related role within a regulated manufacturing environment.

• Bachelors degree in Mechanical Engineering, Manufacturing Engineering, or a related field.

• Strong knowledge of manufacturing processes, CNC machining, tooling design, and fabrication methods.

• Proficiency with CAD software and Microsoft Office Suite.

• Proven project management and process improvement experience.

• Excellent problem-solving skills and a data-driven approach to decision-making.

• Familiarity with quality systems, statistical process control, and root cause analysis.

• Commitment to maintaining high safety, quality, and environmental standards.

Desired Qualifications:

• Green Belt or Lean Six Sigma certification.

• Hands-on experience with continuous improvement methodologies and lean manufacturing tools.

• Knowledge of medical device manufacturing standards and regulatory compliance.

• Experience leading cross-functional teams in a fast-paced production environment.

• Strong communication and collaboration skills across departments.

(Must be authorized to work in the United States. Sponsorship is not available for this role.)