1) Operational Leadership & P&L Ownership

• Own full operational P&L, including cost of goods sold (COGS), gross margin, labor efficiency, capital expenditures, and operating budgets.

• Partner closely with Finance to develop, manage, and forecast annual operating plans, budgets, and multi-year capacity and capital plans.

• Drive margin expansion through yield improvement, cost reduction initiatives, make/buy analysis, and operational leverage.

• Establish clear accountability for financial and operational performance across all operations functions.

2) Manufacturing & Operations Execution (Subtractive + Additive)

• Lead day-to-day manufacturing operations across all processes including powder processing, forming, sintering/HIP, machining/grinding, finishing, inspection, packaging, and additive/patient-specific manufacturing workflows.

• Ensure safe, compliant, and efficient execution across all production activities.

• Drive throughput, on-time delivery, yield, and quality performance while balancing capacity constraints and commercial demand.

3) ERP & Systems Ownership (Microsoft Business Central)

• Serve as executive owner of the Company’s Microsoft Business Central ERP system.

• Ensure accurate and disciplined use of ERP for inventory management, production scheduling, costing, lot traceability, purchasing, and financial reporting.

• Partner with IT, Finance, and Operations teams to optimize ERP workflows, reporting, and system enhancements.

• Ensure ERP data integrity supports regulatory requirements (traceability, DHR/DMR), financial reporting, and operational decision-making.

4) Production Planning & Scheduling Coordination

• Oversee and coordinate closely with the Production Scheduler to align manufacturing schedules with commercial demand, inventory targets, and capacity constraints.

• Balance short-term execution with long-term planning across standard products and patient-specific/custom work.

• Establish robust Sales & Operations Planning (S&OP) and demand planning processes appropriate for a regulated medical device manufacturer.

5) Quality System Integration & Regulatory Readiness

• Partner with Quality and Regulatory leadership to ensure all operations comply with ISO 13485, FDA Quality System requirements (21 CFR 820), and internal design transfer standards.

• Own operational readiness for audits, inspections, validations, and regulatory submissions as they relate to manufacturing and operations.

• Ensure disciplined documentation, lot traceability, nonconformance handling, CAPA execution, and continuous improvement.

6) New Product Introduction (NPI) & Scale-Up

• Lead operations involvement in design transfer, process development, validation (IQ/OQ/PQ), and production ramp for new products.

• Establish and enforce clear NPI gating criteria from prototype through commercial launch.

• Ensure operational readiness supports commercial timelines without compromising quality or compliance.

7) Supply Chain & Vendor Management

• Oversee supply chain strategy including supplier qualification, performance management, dual sourcing, and risk mitigation.

• Evaluate and manage external manufacturing partners, specialty processors, and critical vendors.

• Ensure continuity of supply while maintaining quality, cost, and delivery performance.

8) Leadership, Organization & Culture

• Build, lead, and develop a high-performing operations organization across manufacturing, production planning, facilities interfaces, and operational excellence.

• Establish clear performance metrics, accountability, and succession planning for key operational roles.

• Foster a culture of safety, compliance, continuous improvement, and operational discipline.

9) Metrics, Reporting & Board Communication

• Establish and maintain an operational KPI framework including:

o Safety and compliance metrics

o Yield, scrap, OEE, throughput, and cycle time

o On-time delivery and backlog

o COGS, labor efficiency, and margin performance

o Quality trends (NCs, CAPAs, complaints)

• Prepare and present operations updates to executive leadership and the Board of Directors.

Qualifications

Required

• Bachelor’s degree in Engineering, Operations, or related technical discipline (Materials Science, Mechanical, Chemical, Biomedical, or similar).

• 12+ years of progressive leadership experience in manufacturing and operations, including senior-level responsibility.

• Demonstrated P&L ownership and experience managing budgets, margins, and capital investments.

• Experience leading operations in a regulated manufacturing environment (medical device strongly preferred).

• Proven ability to scale manufacturing operations while maintaining quality and compliance.

Strongly Preferred

• Experience in advanced ceramics manufacturing and/or additive manufacturing environments.

• Familiarity with Microsoft Business Central or comparable ERP systems.

• Experience with patient-specific or custom medical device manufacturing workflows.

• Lean, Six Sigma, or equivalent operational excellence experience.

Compensation & Benefits

SINTX offers a competitive executive compensation package, including base salary, performance-based incentives, equity participation, and comprehensive benefits. Compensation is commensurate with experience and aligned with market benchmarks for senior operations leadership in regulated medtech manufacturing.