Manufacturing Engineering Manager

Manufacturing Engineering Manager

We are seeking a hands-on Manufacturing Engineering Manager to lead a team of manufacturing engineers and execute high-impact initiatives across diagnostic product lines. This role combines people leadership with direct ownership of large projects aimed at improving manufacturability, quality, flow, validation, supplier performance, and cost. The ideal candidate will have strong experience in medical device or equipment manufacturing, disciplined project execution, and a proven ability to drive Lean systems and operational excellence in a regulated environment.

• Lead, coach, and develop the Manufacturing Engineering team while setting priorities and driving accountability.
• Manage a portfolio of manufacturing projects that improve safety, quality, delivery, cost, and scalability.
• Drive Lean, Six Sigma, and problem-solving initiatives to reduce waste, variation, defects, and process disruption.
• Develop and optimize manufacturing processes to support reliable production and product transfer.
• Collaborate 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, and IEC standards.
• Partner with Supply Chain leadership to enhance supplier performance and manufacturing readiness through technical collaboration, issue resolution, and process improvement.
• Utilize metrics and data analysis to prioritize actions, monitor results, and deliver measurable operational improvements.

• 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 compliance 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.

• Experience with metal fabrication/finishing, PC board manufacturing, and equipment assembly processes.
• Project and portfolio management skills, with the ability to prioritize initiatives, allocate resources, and deliver complex manufacturing projects on time.
• Operational excellence and continuous improvement focused on efficiency, throughput, defect reduction, and daily manufacturing performance.
• Quality systems and regulatory compliance experience, 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.

This is a Permanent position based out of Saint…