Manufacturing Manager

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

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.

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.

Essential Duties And Responsibilities

• 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.

Required Education And Experience

• 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.
• Process Validation
• 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.
• Position requires a hands on approach. Must be willing 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 preferred.
• Excellent verbal and written communication skills

Physical Requirements

• 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.

Equal Employment Opportunity

Spectral AI, Inc. is an equal opportunity and affirmative action employer. All applicants will be considered for employment without regard to race, color, ancestry, national origin, sex, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, protected veteran status, or any other characteristic protected by applicable federal, state or local laws.