MedTech Ops Leader: Scale Manufacturing & Supply Chain

Inquis Medical, Inc.; Menlo Park (CA); On-site; USD 210,000 - 250,000; Full time

Job summary

Inquis Medical, Inc. is seeking a Senior Director of Operations to lead and scale manufacturing and operations for Class II sterile medical devices.

You will build internal production capabilities, implement lean practices, and manage MRP systems to support growth from pilot to high-volume output. You will oversee supply chain development, regulatory compliance (FDA/ISO), and quality management, while building a high-performing operations organization across manufacturing, facilities, and

Qualifications

• 10+ years of operations leadership experience in the medical device industry.
• Previous Sr Director of Operations role in a medical device startup (strongly preferred).
• Proven track record scaling manufacturing operations for Class II medical devices, preferably EP or minimally invasive cardiovascular devices.
• Experience with single-use disposable sterile medical device and capital equipment production.
• Experience in startup and high-growth environments.
• Experience working within 21 CFR 820, 21 CFR Part 11, and/or ISO 13485 compliant quality systems.
• Demonstrated success building MRP systems and supply chain operations from early stage.
• Experience with direct-to-hospital sales and distribution models.

Responsibilities

• Lead end-to-end manufacturing and operations for scalable growth of Class II sterile devices.
• Build internal production capabilities and evaluate external production options.
• Design and optimize production workflows ensuring quality, efficiency, and regulatory compliance.
• Implement lean manufacturing principles and drive continuous improvement initiatives.
• Build comprehensive MRP systems from inception using NetSuite.
• Develop inventory strategies for materials, components, and finished goods.
• Create demand forecasting models and production planning processes.
• Implement supply chain risk management and business continuity plans.
• Ensure FDA and ISO quality systems compliance and support regulatory submissions.
• Lead cross-functional teams and establish organizational processes.

Skills

GMP knowledge

Scale operations teams

MRP systems

FDA/ISO regulation

Budgets & P&L

Cross-functional collaboration

Project management

Negotiation

Communication skills

Statistical techniques

Education

Bachelor's degree in Engineering/Operations

MBA or advanced degree

ASQ / APICS / PMP certifications

Tools

NetSuite

Job description

Inquis Medical, Inc. is seeking a Senior Director of Operations to lead and scale manufacturing and operations for Class II sterile medical devices.

You will build internal production capabilities, implement lean practices, and manage MRP systems to support growth from pilot to high-volume output. You will oversee supply chain development, regulatory compliance (FDA/ISO), and quality management, while building a high-performing operations organization across manufacturing, facilities, and