Director of Medical Device Manufacturing - Ceramic Implants at SINTX

Salt Lake City, Utah, United States -

Full Time

Start Date

Immediate

Expiry Date

09 Jul, 26

Salary

195000.0

Posted On

10 Apr, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Medical Device Manufacturing, Ceramic Processing, FDA QSR, ISO 13485, Lean Manufacturing, Six Sigma, Process Validation, Production Planning, Capital Equipment Planning, Supply Chain Management, Regulatory Compliance, Team Leadership, ERP Systems, MRP Systems, Risk Management, Process FMEA

Industry

Biotechnology Research

Description

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

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Responsibilities

The Director of Manufacturing oversees all strategic and operational activities for ceramic implant production, ensuring compliance with FDA and ISO standards. This role manages production planning, process validation, capital equipment, and cross-functional collaboration to drive operational excellence.