Vice President of Operations

Company Overview

SINTX Technologies, Inc. is an advanced ceramics and biomaterials company focused on developing, manufacturing, and commercializing next-generation medical device solutions. SINTX is one of a limited number of global manufacturers capable of producing implant-grade ceramic biomaterials, with a core platform in silicon nitride (SiN) and expanding capabilities in SiN/PEEK composites, additive manufacturing, and patient-specific solutions.

Position Summary

The Vice President of Operations is a senior executive leadership role responsible for the end-to-end operational performance of SINTX Technologies. This role oversees manufacturing, operations planning, systems, and financial performance across both subtractive ceramic manufacturing and additive/patient-specific manufacturing platforms. The VP of Operations owns operational execution, scalability, and accountability, including full P&L responsibility, ERP system leadership (Microsoft Business Central), cross-functional coordination, and continuous improvement. This role ensures that operational strategy aligns with corporate objectives, regulatory requirements, and commercial growth plans while maintaining the highest standards of quality, safety, and cost control. This is a hands-on, highly visible leadership position requiring deep operational judgment, strong financial acumen, and the ability to lead complex, regulated manufacturing environments.

Key Responsibilities

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.