Manufacturing Manager

Position Summary

Spectral AI is seeking an experienced team-oriented Manufacturing Manager to lead Manufacturing and Procurement operations of our medical products. The position will report to the General Manager and will collaborate with contract manufacturers, suppliers, and internal cross functional teams to ensure the efficient production of safe products that meet customer requirements.

• Provide overall leadership to the Manufacturing Engineering and Procurement teams.
• Establish operational goals/strategies and related departmental performance KPI’s.
• Responsible for Regulatory compliance and representing Manufacturing and Procurement operations in periodic ISO 13485, FDA, and State of Texas compliance inspections.
• Responsible for manufacturing process development, process risk management and process validation activities.
• Manages successful design transfer of new products to contract manufacturers.
• Lead Sales and Operations planning meetings to ensure on time delivery of high quality, safe products that meet customer requirements.
• Develop department budgets and manage expenses and capital needs within budget guidelines.
• Coordinate timely investigations, root cause analysis and implementation of corrective/preventative actions to address CAPA’s and nonconformances related to Manufacturing/Procurement.
• Support internal cross functional teams related to New Product Development, Sustaining Engineering, Quality Improvement and other projects as assigned by Senior Leadership.
• Build a highly skilled, highly regarded and motivated customer focused team that mentors individual members to achieve their full potential.
• Develop improvement strategies based on the business goals and aligned with Lean Manufacturing principles in compliance with applicable agency regulations.

Spectral AI is seeking an experienced team-oriented Manufacturing Manager to lead Manufacturing and Procurement operations of our medical products. The position will report to the General Manager and will collaborate with contract manufacturers, suppliers, and internal cross functional teams to ensure the efficient production of safe products that meet customer requirements.

• Provide overall leadership to the Manufacturing Engineering and Procurement teams.
• Establish operational goals/strategies and related departmental performance KPI’s.
• Responsible for Regulatory compliance and representing Manufacturing and Procurement operations in periodic ISO 13485, FDA, and State of Texas compliance inspections.
• Responsible for manufacturing process development, process risk management and process validation activities.
• Manages successful design transfer of new products to contract manufacturers.
• Lead Sales and Operations planning meetings to ensure on time delivery of high quality, safe products that meet customer requirements.
• Develop department budgets and manage expenses and capital needs within budget guidelines.
• Coordinate timely investigations, root cause analysis and implementation of corrective/preventative actions to address CAPA’s and nonconformances related to Manufacturing/Procurement.
• Support internal cross functional teams related to New Product Development, Sustaining Engineering, Quality Improvement and other projects as assigned by Senior Leadership.
• Build a highly skilled, highly regarded and motivated customer focused team that mentors individual members to achieve their full potential.
• Develop improvement strategies based on the business goals and aligned with Lean Manufacturing principles in compliance with applicable agency regulations.

• Bachelor’s or Graduate Degree in Engineering, Operations Management or related field or equivalent experience.
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