Lead Manufacturing Engineering - Lean, ISO 13485

MGC Diagnostics; Saint Paul (MN); On-site; USD 120,000 - 170,000; Full time

Job summary

MGC Diagnostics is seeking a hands-on Manufacturing Engineering Manager to lead a team of manufacturing engineers and drive high-impact initiatives across its diagnostic product lines. This role combines people leadership with direct ownership of large projects that improve manufacturability, quality, flow, validation, supplier performance, and cost.

The ideal candidate brings strong medical device manufacturing experience, disciplined project execution, and a proven ability to drive Lean

Qualifications

• Bachelor’s degree in Engineering, Technology, or a related technical field.
• 10+ years of engineering experience in manufacturing, process, industrial, mechanical, or operations engineering roles with progressively increasing scope, responsibility, and impact.
• 5+ years of experience in a management or formal people leadership role, including leading engineers, developing talent, assigning priorities, and driving accountability across cross-functional manufacturing initiatives.
• Experience implementing structured project management methods to prioritize, execute, and monitor multiple initiatives.
• Demonstrated experience driving continuous improvement using Lean, Six Sigma, or other operational excellence systems.
• Strong knowledge of manufacturing process development, process validation, root cause analysis, and corrective/preventive action methodologies.
• Experience in a regulated medical device environment with working knowledge of ISO 13485 and validation requirements.
• Experience improving product yield, quality, and manufacturability for electromechanical or diagnostic equipment.
• Experience partnering with supply chain and suppliers on sourcing strategy, supplier development, quality improvement, and cost reduction initiatives.
• Strong analytical, communication, and cross-functional collaboration skills, with the ability to influence change and deliver measurable business results.
• Familiarity with ERP, MES, PLM, or other business systems used to support manufacturing performance and change control.

Responsibilities

• Lead, coach, and develop the Manufacturing Engineering team while setting priorities and driving accountability.
• Manage a project portfolio of manufacturing projects that improve safety, quality, delivery, cost, and scalability.
• Drive Lean, Six Sigma, and problem-solving in the form of Projects, Kaizen Events, and other ad-hoc events, all in effort to reduce waste, variation, defects, and process disruption.
• Develop and optimize manufacturing processes to support reliable production and product transfer.
• Partner with Operations, Quality, Supply Chain, and R&D to execute cross-functional improvements and resolve manufacturing issues.
• Ensure compliance with quality system requirements, validation standards, and regulated manufacturing practices, including FDA 21 CFR 820, ISO 13485, ISO 14971, and IEC 60601-1.
• Partner with Supply Chain leadership with supplier performance and manufacturing readiness through technical collaboration, issue resolution, and process improvement.
• Use metrics and data analysis to prioritize actions, monitor results, and deliver measurable operational improvements.

Skills

Lean Six Sigma

Project management

Data analysis

Cross-functional collaboration

Leadership

Education

Bachelor’s degree in Engineering

Tools

ERP systems

MES systems

PLM systems

Job description

MGC Diagnostics is seeking a hands-on Manufacturing Engineering Manager to lead a team of manufacturing engineers and drive high-impact initiatives across its diagnostic product lines. This role combines people leadership with direct ownership of large projects that improve manufacturability, quality, flow, validation, supplier performance, and cost.

The ideal candidate brings strong medical device manufacturing experience, disciplined project execution, and a proven ability to drive Lean