Senior Manager, Medical Device Manufacturing & Compliance

Spectral MD Inc; Dallas (TX); On-site; USD 110,000 - 150,000; Full time

Job summary

Spectral AI, Inc. is seeking a Manufacturing Manager to lead Manufacturing and Procurement teams in Dallas, Texas. The role reports to the General Manager and collaborates with contract manufacturers, suppliers, and cross-functional groups to ensure safe, compliant, and on-time production of medical products.

You will drive Lean initiatives, oversee quality and regulatory activities, manage budgets, and mentor a skilled team to meet demanding timelines.

Qualifications

• Bachelor’s or graduate degree in Engineering, Operations Management or related field.
• 5 years of FDA/ISO 13485 regulated Medical Device Manufacturing and Supply Chain experience.
• Process Validation experience.
• Deep understanding of FDA/ISO13485 QMSR with audit experience.
• Experience managing contract manufacturing of medical products.
• Multidisciplinary environment experience producing complex medical products.
• Hands-on approach and ability to pitch in during peak activity.

Responsibilities

• Lead Manufacturing Engineering and Procurement teams.
• Establish goals/ KPIs and budget adherence.
• Ensure regulatory compliance and represent in ISO 13485, FDA inspections.
• Oversee manufacturing process development, validation, and risk management.
• Lead design transfer to contract manufacturers.
• Drive S&OP meetings for on-time delivery of high-quality products.
• Develop department budgets and manage expenses/capital needs.
• Coordinate CAPA investigations and root cause analysis.
• Support NPD, Sustaining Engineering, and Quality Improvement projects.
• Mentor and develop a skilled, customer-focused team.

Skills

Regulatory compliance

Leadership

Cross-functional collaboration

Process validation

Education

Bachelor’s or Graduate degree in Engineering / Operations Management

5+ years FDA/ISO 13485 regulated medical device manufacturing experience

Tools

NetSuite ERP

Greenlight Guru EQMS

Job description

Spectral AI, Inc. is seeking a Manufacturing Manager to lead Manufacturing and Procurement teams in Dallas, Texas. The role reports to the General Manager and collaborates with contract manufacturers, suppliers, and cross-functional groups to ensure safe, compliant, and on-time production of medical products.

You will drive Lean initiatives, oversee quality and regulatory activities, manage budgets, and mentor a skilled team to meet demanding timelines.