Senior Medical Device Manufacturing & Compliance Leader

ADP, Inc.; Dallas (TX); On-site; USD 108,000 - 132,000; Full time

Job summary

Spectral AI, Inc. seeks an experienced Manufacturing Manager in Dallas, TX to lead Manufacturing and Procurement operations for medical products.

This role reports to the General Manager and collaborates with contract manufacturers, suppliers, and internal teams to ensure safe, compliant, high-quality production. Ideal candidates will have strong leadership, deep regulatory knowledge, and hands-on experience in process validation and cross-functional execution, with a focus on Lean principles

Qualifications

• Bachelor’s or graduate degree in engineering, operations management or related field.
• 5+ years in FDA/ISO 13485 regulated medical device manufacturing and supply chain.
• Experience in contract manufacturing of medical products.
• Hands-on leader with mentoring and team-building experience.

Responsibilities

• Provide leadership to Manufacturing Engineering and Procurement teams.
• Ensure compliance with FDA/ISO 13485, and state inspections.
• Manage manufacturing process development, validation and risk management.
• Lead transfer of new products to contract manufacturers and audits.

Skills

Leadership

Regulatory compliance

Process validation

Lean manufacturing

Cross-functional

Education

Engineering degree

Tools

NetSuite ERP

Greenlight Guru EQMS

Job description

Spectral AI, Inc. seeks an experienced Manufacturing Manager in Dallas, TX to lead Manufacturing and Procurement operations for medical products.

This role reports to the General Manager and collaborates with contract manufacturers, suppliers, and internal teams to ensure safe, compliant, high-quality production. Ideal candidates will have strong leadership, deep regulatory knowledge, and hands-on experience in process validation and cross-functional execution, with a focus on Lean principles