Manufacturing Manager

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

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Manufacturing Manager

FullTime Management Dallas, TX, US

3 days ago Requisition ID: 1184

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:

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.

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.