Senior 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.)