Director, Technical Operations - Medical Device Manufacturing

Hanger; Phoenix (AZ); On-site; USD 150,000 - 210,000; Full time

Benefits offered by this job

Competitive compensation packages

8 paid national holidays & 4 floating

PTO: Vacation & Sick time

Medical, dental, and vision benefits

401k savings and retirement plan

Relocation assistance

Flexible work schedules

Mentorship programs

Job summary

Hanger, Inc. seeks a Director of Technical Operations – Manufacturing & Fabrication to lead and optimize technical operations across multiple facilities, ensuring high-quality O&P products and efficient production processes.

The role drives strategic manufacturing initiatives, oversees cross-functional teams, and champions Lean, Six Sigma, and automation to enhance performance and compliance with FDA/ISO standards.

Qualifications

• 10+ years of experience in manufacturing / fabrication, operations, or technical leadership, preferably in medical devices.
• 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.

Responsibilities

• 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 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 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 (FDA, ISO 13485, CMS, HIPAA).
• Implement quality control measures to reduce defects and improve product reliability.
• Partner with Quality Assurance to drive continuous improvements in manufacturing / fabrication compliance and safety.
• Lead root cause analysis and corrective actions for technical manufacturing deviations and non-conformities.

Skills

Lean Manufacturing

Six Sigma

Operational leadership

CAD/CAM

3D printing

Regulatory compliance

QMS

Multi-site leadership

Driver's license

Education

Bachelors in manufacturing / fabrication or related field

Master’s in engineering or Operations Management

Tools

ERP/MRP systems

CAD/CAM

3D printing

Job description

Hanger, Inc. seeks a Director of Technical Operations – Manufacturing & Fabrication to lead and optimize technical operations across multiple facilities, ensuring high-quality O&P products and efficient production processes.

The role drives strategic manufacturing initiatives, oversees cross-functional teams, and champions Lean, Six Sigma, and automation to enhance performance and compliance with FDA/ISO standards.