Director, Technical Operations – Manufacturing & Fabrication

Role Overview

• 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.
• 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.
• 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.
• 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.

Requirements

• 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.

Tech Stack

• Assembly
• ERP

Benefits

• 8 Paid National Holidays & 4 additional Floating Holidays
• PTO that includes Vacation and Sick time
• Medical, Dental, and Vision Benefits
• 401k Savings and Retirement Plan
• Paid Parental Bonding Leave for New Parents
• Flexible Work Schedules and Part-time Opportunities
• Generous Employee Referral Bonus Program
• Mentorship Programs
• Mentor and Mentee
• Student Loan Repayment Assistance by Location
• Relocation Assistance
• Regional & National traveling CPO/CO/CP opportunities
• Volunteering for Local and National events such as Hanger’s BAKA Bootcamp and EmpowerFest