Senior Manufacturing Engineer

Senior Manufacturing Engineer

About the Role:
The Senior Manufacturing Engineer will lead the development and optimization of advanced manufacturing processes within an ISO 13485-certified environment. This role focuses on continuous improvement, lean manufacturing, and precision CNC machining to enhance product quality, reduce costs, and streamline operations. The position requires strong technical expertise, hands-on process leadership, and experience mentoring junior engineers in a fast-paced, high-precision production setting.

Responsibilities:

• Develop, implement, and optimize manufacturing processes to meet quality, efficiency, and regulatory standards.

• Lead process validation, documentation, and improvement efforts in compliance with ISO 13485 and related quality systems.

• Utilize lean manufacturing, continuous improvement, and 5S principles to enhance operational performance and reduce waste.

• Evaluate and refine CNC machining operations, tooling design, and process flow for precision manufacturing.

• Conduct cost estimation, process analysis, and capacity planning to support new and existing product lines.

• Oversee the installation, testing, and maintenance of manufacturing equipment and production systems.

• Mentor and train junior engineers, providing technical guidance and professional development support.

• Collaborate with cross-functional teams to resolve production challenges and implement process improvements.

• Ensure manufacturing practices adhere to safety, quality, and environmental regulations.

• Identify and integrate automation and digital manufacturing technologies to drive process innovation.

Qualifications:

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

• Minimum of 10 years of manufacturing engineering experience, with at least 5 years of continuous tenure at one organization.

• Proven experience working in an ISO 13485-certified or other regulated manufacturing environment.

• Expertise in CNC machining processes, tool design, and process optimization.

• Demonstrated application of lean manufacturing, continuous improvement, and 5S methodologies.

• Strong knowledge of CAD software, project management tools, and data-driven process control.

• Exceptional analytical, problem-solving, and communication skills.

• Proven ability to manage complex projects and lead cross-functional teams.

• Commitment to quality, safety, and compliance in all manufacturing operations.

Desired Qualifications:

• Six Sigma Green Belt certification or equivalent process improvement training.

• Experience mentoring and developing engineering talent within a manufacturing organization.

• Familiarity with automation, robotics, and advanced manufacturing technologies.

• Background in medical device manufacturing or other precision, high-regulation industries.

• Strong record of driving measurable cost reductions, efficiency gains, and quality improvements.

This position offers a competitive salary, comprehensive benefits, and the opportunity to lead impactful process improvements in a world-class, ISO-certified manufacturing environment.