Summary/Objective

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.

Essential Functions
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.

Competencies/Success Factors

• 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.

Supervisory Responsibility
Supervises the Manufacturing Engineering team.

Work Environment
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.

Physical Demands
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

• 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.

Travel
Limited travel, < than 25%

Required Education and Experience

• 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 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.

Additional Eligibility Qualifications
None required for this position.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.