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