Manufacturing Engineering Manager

Minnetronix Medical, Inc.; Saint Paul (MN); On-site; USD 150,000 - 190,000; Full time

Job summary

Minnetronix Medical, Inc. seeks an experienced Manufacturing Engineering Manager to lead the Manufacturing Engineering organization and drive operational excellence across manufacturing operations, quality, and cost performance.

You will provide technical direction to engineers and technicians, oversee equipment qualification and validation, and collaborate with Production, Quality, and Supply Chain to scale capabilities for current and future products.

Qualifications

• Bachelor of Science in Mechanical/Manufacturing/Industrial Engineering or related field required.
• Minimum 10 years engineering experience with at least 2 years in leadership in manufacturing/operations.
• Experience in regulated environments with strong quality systems knowledge (FDA QSR, ISO 13485/9001).
• Proven ability to lead diverse technical teams, communicate effectively, and drive improvements.

Responsibilities

• Lead and develop a team of Manufacturing Engineers and Technicians.
• Drive Lean/Six Sigma process improvements to enhance productivity and quality.
• Oversee capital projects, equipment lifecycle management, and automation initiatives.
• Ensure regulatory compliance and support quality systems and validations.
• Collaborate with Production, Quality, Supply Chain, and CI to meet business goals.
• Monitor performance metrics and drive cost reduction and efficiency.

Skills

Leadership

Regulatory knowledge

Lean Manufacturing

Six Sigma

Problem solving

Communication

Education

Bachelor of Science in Mechanical/Manufacturing/Industrial Engineering

Master's degree in Engineering (preferred)

Job description

Job Summary:

The Manufacturing Engineering Manager is responsible for developing, leading, and continuously improving the Manufacturing Engineering organization in support of operational excellence, product quality, customer satisfaction, and business objectives. This role provides leadership and technical direction to Manufacturing Engineers and Manufacturing Technicians responsible for sustaining manufacturing operations, process optimization, equipment and automation systems, new technology implementation, capital projects, and continuous improvement initiatives. The role operates within the Operations organization and serves as a key leader in driving manufacturing performance, nonconformance timeliness, productivity improvements, and cost reduction efforts. The Manufacturing Engineering Manager partners closely with Production, Quality, Supply Chain, and Continuous Improvement to ensure manufacturing systems are safe, reliable, scalable, and capable of meeting current and future business needs.

Job Duties and Responsibilities:

Manufacturing Engineering Leadership & Team Development

• Lead, mentor, and develop a team of Manufacturing Engineers and Manufacturing Technicians supporting manufacturing operations.
• Establish individual and team goals aligned with operational and strategic objectives.
• Provide ongoing coaching, performance management, training, and career development opportunities.
• Develop workforce planning and resource strategies to support production demands and long-term growth objectives.
• Foster a culture of accountability, continuous improvement, collaboration, and operational excellence.
• Partner with Operations leadership to effectively prioritize resources and execute department objectives.
• Oversee activities associated with the Material Review Board (MRB) area and support disposition processes, corrective actions, and continuous improvement initiatives.

Manufacturing Process & Equipment Leadership

• Provide technical leadership for manufacturing processes, equipment, automation systems, tooling, fixtures, and production technologies.
• Lead process optimization efforts using Lean Manufacturing, Six Sigma, and data-driven problem-solving methodologies.
• Support equipment selection, implementation, qualification, validation, maintenance strategies, and lifecycle management.
• Establish and maintain manufacturing engineering standards, best practices, and documentation requirements.

Operational Excellence & Continuous Improvement

• Lead initiatives focused on productivity improvement, waste reduction, labor optimization, and cost reduction.
• Drive continuous improvement activities across manufacturing processes and supporting systems.
• Identify opportunities to improve equipment utilization, process capability, capacity, and overall operational performance.
• Support development and execution of strategic manufacturing technology roadmaps.
• Participate in value stream improvement initiatives and operational performance reviews.
• Develop and monitor key manufacturing engineering metrics and performance indicators.

Regulatory Compliance & Quality Systems

• Ensure compliance with applicable regulatory requirements, company policies, and quality management systems.
• Support manufacturing validations, process qualifications, and equipment qualifications as required.
• Participate in internal and external audits and support remediation activities when necessary.
• Promote a culture of quality and compliance throughout manufacturing operations.
• Ensure manufacturing engineering activities adhere to established documentation and change control requirements.

Financial & Business Performance

• Support annual operating plans, budget development, and resource forecasting activities.
• Drive cost reduction and operational efficiency initiatives.
• Monitor and manage departmental spending associated with equipment, tooling, automation, and capital projects.
• Support achievement of operational and financial objectives through effective manufacturing engineering leadership.

Qualifications

Required

• Bachelor of Science degree in Mechanical Engineering, Manufacturing Engineering, Industrial Engineering, or a related technical discipline.
• Minimum of 10 years of engineering experience, including at least 2 years of engineering leadership experience in manufacturing, process engineering, or operations support environments
• Demonstrated success leading technical teams in a regulated environment.
• Strong knowledge of manufacturing processes, process improvement methodologies, and production equipment
• Experience with FDA Quality System Regulations (QSR), ISO 13485, and/or ISO 9001 standards.
• Excellent communication, problem-solving, decision-making, coaching, and leadership skills.

Preferred

• Master of Science degree in Engineering or related technical field.
• Previous mechanical or manufacturing engineering management experience.
• Experience leading Class II and/or Class III medical device operations.
• Lean Manufacturing and/or Six Sigma certification.
• Experience working in a highly regulated industry such as Medical, Aerospace, Semi-Conductor or similar.

Working Conditions

• Office environment
• Manufacturing floor
• Engineering laboratory
• Machine shop environment