Director of Manufacturing Operations at Medical Engineering Consultants (MEC)

Job 2754 - Director of Manufacturing Operations - Contract located in Fort Lauderdale, Florida

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages.

MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts).

MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations.

Applicants must be authorized to work in the U.S. in accordance with applicable law. This position is not eligible for employer-sponsored work authorization now or in the future.

Onsite

Overview

MEC is seeking a Director of Manufacturing Operations to lead and scale manufacturing for complex, regulated medical device environments. This individual will be responsible for end-to-end production operations, process development, and organizational growth, ensuring high-quality, compliant, and efficient manufacturing execution.

Key Responsibilities

Manufacturing Leadership & Operations

• Lead day-to-day manufacturing operations across multi-product or multi-program environments
• Own production planning, scheduling, capacity management, and throughput optimization
• Manage facility operations including cleanroom environments and controlled manufacturing conditions
• Build and scale manufacturing teams, including hiring, training, and organizational structure design

Process Development & Engineering

• Oversee manufacturing processes across metals and polymer-based devices or components
• Drive process development, validation (IQ/OQ/PQ), and design transfer from R&D into production
• Lead continuous improvement initiatives focused on yield, scrap reduction, cycle time, and cost of goods
• Specify, qualify, and maintain equipment, tooling, and production systems

Quality & Regulatory

• Partner with Quality and Regulatory teams to ensure compliance with applicable standards (e.g., ISO 13485, FDA QSR)
• Ensure compliant execution of DHRs, traceability, and cleanroom controls
• Support audits, CAPA, nonconformance investigations, and complaint handling activities
• Establish and maintain a strong quality-first culture across manufacturing

Supply Chain & Cross-Functional Leadership

• Oversee procurement, supplier qualification, and incoming inspection processes
• Collaborate with R&D, Quality, Regulatory, and leadership on scale-up and operational strategy
• Drive alignment across product development and manufacturing execution

Qualifications

Required

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Manufacturing, Materials, or related)
• 10+ years of experience in medical device or regulated manufacturing environments
• Demonstrated leadership scaling manufacturing operations in low-to-mid volume settings
• Strong experience with process validation, design transfer, and production scale-up
• Experience working within ISO 13485 and FDA-regulated environments
• Experience managing cleanroom manufacturing operations

Preferred

• Experience with catheter-based, minimally invasive, or complex assembly manufacturing
• Hands-on experience with extrusion or polymer processing techniques
• Familiarity with metals processing (e.g., laser cutting, welding, forming)
• Lean / Six Sigma certification and track record of continuous improvement execution
• Experience leading multi-product or multi-business-unit manufacturing environments

MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee.

• Sponsorship is not available for this position

AAP/EEO DFWP

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.