HFN: Director, Technical Operations - Manufacturing & Fabrication

Job Description

Job Description

Overview

The Director, Technical Operations – Manufacturing & Fabrication will lead and optimize technical operations across multiple manufacturing and fabrication facilities. This role will contribute significantly to the company’s growth strategy by implementing innovative strategies to drive operational excellence, ensure the highest quality of orthotic and prosthetic (O&P) products, and enhance efficiency in production processes through the implementation and maintenance of new technology. This role will oversee the technical aspects of manufacturing and fabrication processes. It involves managing the technical operations team, optimizing production efficiency, and ensuring the maintenance of manufacturing equipment.

Responsibilities

TRAVEL: 30 to 40% depending on business needs

Operational Leadership & Strategy

• Lead new product introductions and product transfers from suppliers into the facilities in coordination with key stakeholders.
• Develop and implement strategic initiatives to optimize manufacturing and fabrication technical process efficiency across fabrication and manufacturing.
• Lead technical operations, ensuring efficiency, quality, and compliance with industry regulations.
• Collaborate with R&D, engineering, and clinical teams to support the development and production of innovative O&P solutions.
• Lead the design, development, and maintenance of manufacturing and equipment.
• Analyze production data and metrics to identify areas for improvement and implement corrective actions.
• Drive continuous improvement initiatives, including Lean, Six Sigma, and automation strategies to enhance production efficiency.
• Establish and monitor key performance indicators (KPIs) to measure operational success.

Manufacturing & Fabrication Excellence

• Evaluate and implement new manufacturing technologies, including CAD/CAM, 3D printing, and automated fabrication techniques.
• Ensure compliance with FDA, ISO, and other relevant regulatory standards for medical devices.
• Maintain strong vendor and supplier relationships to ensure the availability of high-quality materials and equipment.

Team Leadership & Development

• Lead, mentor, and develop a team of manufacturing, engineering, and technical operations professionals.
• Foster a culture of accountability, collaboration, and innovation within the fabrication and manufacturing teams.

Quality & Compliance

• Ensure all production processes adhere to industry best practices and regulatory requirements (e.g., FDA, ISO 13485, CMS, HIPAA).
• Implement quality control measures to reduce defects and improve product reliability.
• Partner with the Quality Assurance team to drive continuous improvements in manufacturing / fabrication compliance and safety.
• Lead root cause analysis and corrective actions for technical manufacturing deviations and non-conformities.

Qualifications

Required:

• Bachelor’s degree in manufacturing / fabrication, business administration, or a related field.
• 10+ years of experience in manufacturing / fabrication, operations, or technical leadership, preferably in medical devices or healthcare products.
• Proven experience managing multi-site manufacturing operations, including fabrication and assembly processes.
• Strong background in Lean Manufacturing, Six Sigma, and operational excellence methodologies.
• Understanding of CAD/CAM, 3D printing, and traditional O&P fabrication techniques.
• Experience with quality management systems (QMS) and regulatory compliance in medical device manufacturing.
• Strong leadership, team building, and communication skills.
• Must have, or be eligible to obtain, a valid driver’s license and driving record within the standards outlined within Hanger’s Motor Vehicle Safety Policy and Procedures. 

Preferred:

• Master’s degree in engineering or Operations Management.
• Experience in orthotics and prosthetics manufacturing.
• Familiarity with ERP/MRP systems for manufacturing and supply chain management.
• Knowledge of automation and digital manufacturing trends in the O&P industry.