Medical Device Manufacturing & Procurement Lead

Spectral AI; Dallas (TX); On-site; USD 110,000 - 160,000; Full time

Job summary

Spectral AI is seeking an experienced Manufacturing Manager to lead Manufacturing and Procurement of medical products. The role reports to the General Manager and collaborates with contract manufacturers, suppliers, and internal cross-functional teams to ensure efficient production of safe products that meet customer requirements.

You will drive process development, CAPA handling, S&OP, budgets, and Lean initiatives while mentoring a high-performing team committed to quality and on-time delivery

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 experience
• Process Validation
• Experience with managing contract manufacturing of medical products
• Experience in multidisciplinary environment producing complex high quality medical products
• Hands-on approach and ability to pitch in during peak activity

Responsibilities

• Provide leadership to Manufacturing Engineering and Procurement teams
• Establish operational goals/strategies and KPI’s
• Ensure regulatory compliance (ISO 13485, FDA, Texas) inspections
• Lead process development, risk management and validation
• Oversee design transfer to contract manufacturers
• Lead S&OP meetings for on-time, high-quality delivery
• Develop department budgets and manage expenses/capital
• Drive CAPA investigations and corrective actions
• Support cross-functional teams (NPD, Sustaining Eng, Quality)
• Mentor a customer-focused team to reach potential
• Drive Lean initiatives aligned with agency regs

Skills

Leadership

Mentoring

Effective communication

Cross-functional collaboration

Lean manufacturing

Team building

S&OP leadership

Problem solving

Education

Bachelor’s or Graduate Degree in Engineering/Operations Management

Tools

NetSuite ERP

Greenlight Guru EQMS

Job description

Spectral AI is seeking an experienced Manufacturing Manager to lead Manufacturing and Procurement of medical products. The role reports to the General Manager and collaborates with contract manufacturers, suppliers, and internal cross-functional teams to ensure efficient production of safe products that meet customer requirements.

You will drive process development, CAPA handling, S&OP, budgets, and Lean initiatives while mentoring a high-performing team committed to quality and on-time delivery