Manufacturing Engineering Manager

MGC Diagnostics is seeking a hands‑on Manufacturing Engineering Manager to lead a team of manufacturing engineers and execute 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 or equipment manufacturing experience, disciplined project execution, and a proven ability to drive Lean systems and operational excellence in an ISO 13485‑regulated environment.

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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.

• People leadership and team development, including coaching engineers, setting priorities, building accountability, and growing technical capability.
• Project and portfolio management, with the ability to prioritize initiatives, allocate resources, and deliver complex manufacturing projects on time.
• Experience with metal fabrication/finishing, PC board manufacturing, and equipment assembly processes.
• Lean manufacturing and Six Sigma problem solving to eliminate waste, reduce variation, and improve process performance and quality.
• Process development, validation, and transfer, including robust manufacturing methods and smooth transition into production.
• Operational excellence and continuous improvement focused on efficiency, throughput, defect reduction, and daily manufacturing performance.
• Quality systems and regulatory compliance, ensuring alignment with procedures, validation requirements, and medical device standards.
• Experience with supplier development and cross‑functional collaboration to resolve issues and drive operational improvements.
• Data‑driven decision making and results orientation, using metrics and analysis to prioritize actions and deliver business impact.

Supervises the Manufacturing Engineering team. This role operates across office, manufacturing, and warehouse environments. Regular presence on the production floor and in operational areas is expected to support manufacturing, troubleshooting, continuous improvement, and supplier or production readiness activities.

• Frequent standing, sitting, walking, bending, stooping, twisting and occasional crawling.
• Occasional lifting up to 50 lbs., occasional heavier lifting.
• Occasional pushing, pulling and handling of materials.

Limited travel, less than 25%

• Bachelor’s degree in Engineering, Technology, or a related technical field required; advanced technical or business education relevant to manufacturing leadership is valued.
• 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…