Manufacturing Manager

About the Role

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.

Responsibilities

• Provide overall leadership to the Manufacturing Engineering and Procurement teams.
• Establish operational goals/strategies and related departmental performance KPI’s.
• Ensure Regulatory compliance and represent Manufacturing and Procurement operations in periodic ISO 13485, FDA, and State of Texas compliance inspections.
• Oversee manufacturing process development, process risk management, and process validation activities.
• Manage 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, motivated, and customer-focused team that mentors individual members to achieve their full potential.
• Develop improvement strategies based on business goals and aligned with Lean Manufacturing principles in compliance with applicable agency regulations.

Qualifications

• Bachelor’s or Graduate Degree in Engineering, Operations Management, or related field, or equivalent experience.
• 5 years of FDA/ISO 13485 regulated Medical Device Manufacturing and Supply Chain industry experience supporting production of FDA Class II or III medical products.
• Deep understanding of FDA/ISO13485 QMSR requirements with direct experience representing Manufacturing/Supply Chain operations in periodic surveillance audits.
• Demonstrated experience with managing contract manufacturing of medical products.
• Experience working in a multidisciplinary environment producing complex high-quality medical products.
• Effective communicator with a successful track record of mentoring and building effective teams.
• Hands-on approach and willingness to pitch in during peak activity to ensure team objectives and timelines are met.

Preferred Qualifications

• Experience with UL/MET Electrical Safety compliance inspections and ability to support Contract Manufacturer to maintain compliance.
• Lean 6 Sigma Green Belt certification or higher.
• Experience utilizing NetSuite ERP and Greenlight Guru EQMS Systems.
• Excellent verbal and written communication skills.

Physical Requirements

The physical demands described below are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Employee routinely is required to sit; walk; talk and hear; use hands to keyboard.
• The employee is occasionally required to move around the office.
• Specific vision abilities required by this job include close vision, color vision, depth perception, and ability to adjust focus.
• The employee may occasionally lift and/or move up to 30 lbs.

Travel

25% of travel time expected for the position to visit contract manufacturing/supplier locations; both local and national travel may be required.