Director of Medical Device Manufacturing - Ceramic Implants

Description

The Director of Manufacturing leads the strategic and operational execution of all manufacturing activities for a regulated medical device organization specializing in advanced ceramic implant technologies. This role is responsible for ensuring compliant, scalable, and cost-effective production of high-performance ceramic orthopedic and spinal implants, including powder processing, forming, sintering, precision machining, finishing, inspection, and packaging operations.

Requirements

• Provide leadership for all manufacturing operations including production planning, scheduling, staffing, and execution.

• Ensure full compliance with FDA QSR (21 CFR 820/QMSR), ISO 13485, and applicable global regulatory requirements.

• Drive operational excellence initiatives using Lean Manufacturing, Six Sigma, and continuous improvement methodologies.

• Oversee ceramic manufacturing processes including powder formulation, pressing, debinding, sintering, machining, polishing, and sterilization preparation.

• Collaborate with R&D; and Quality to ensure robust process validation (IQ/OQ/PQ) and design transfer activities.

• Establish and manage KPIs related to safety, quality, cost, delivery, throughput, and yield.

• Lead capital equipment planning, automation initiatives, and preventive maintenance strategy.

• Partner with Supply Chain to ensure raw material quality, supplier qualification, and risk mitigation.

• Support audit readiness and interface with regulatory authorities and notified bodies as required.

• Develop and mentor high-performing operations teams, fostering accountability and performance culture.

Required Qualifications

• Bachelor’s or master’s degree in engineering, Materials Science, Manufacturing, or related technical discipline.

• 10–15+ years of progressive leadership experience in medical device manufacturing.

• Deep knowledge of FDA QSR/QMSR and ISO 13485 regulatory requirements.

• Demonstrated experience in ceramic materials processing and high-temperature sintering operations.

• Proven track record of scaling manufacturing operations in a regulated environment.

• Experience with ERP/MRP systems and manufacturing execution systems.

• Strong analytical, leadership, and cross-functional communication skills.

Preferred Experience

• Experience with orthopedic, spine, or load-bearing implant manufacturing.

• Six Sigma Black Belt or Lean certification.

• Experience with ceramic biomaterials such as zirconia, alumina, or composite ceramics.

• Knowledge of risk management (ISO 14971) and process FMEA.

• Experience leading facility expansions or new production line launches.

Success Metrics

• Improved first-pass yield and reduced scrap rates.

• On-time delivery performance above 98%.

• Sustained audit readiness with no major regulatory findings.

• Reduction in manufacturing lead time.

• Strong employee engagement and team development.

Salary Range

$185,000-$195,000 + Bonus + Equity