Director of Operations

About HydroCision

HydroCision is an innovative medical device company specializing in advanced fluid-based surgical instruments for spine and wound care procedures. With manufacturing and engineering support spanning both the U.S. and China, we deliver high-quality, precision devices that improve clinical outcomes and patient care.

Our Billerica, MA office serves as the strategic and operational hub for our U.S. operations. We are a small but highly capable team, and we’re seeking an experienced Operations Director to drive manage global supply chain coordination, oversee day-to-day operations and elevate our quality systems.

Position Overview

This is a critical leadership role for a hands-on, results-driven Operations Manager who can oversee and optimize the company’s end-to-end supply chain, quality assurance, vendor management, and planning. You will work closely with the cross-functional team in Billerica (3 direct reports) and regularly collaborate with our contract manufacturing and sourcing teams in China (approx. 20 employees).

This role requires a strong background in supply chain operations, medical device quality systems, and international manufacturing coordination.

Key Responsibilities

• Manage day-to-day operations including supply chain logistics, inventory management, and procurement

• Oversee production planning and ensure timely delivery of finished goods

• Serve as the primary liaison between the U.S. office and our China-based manufacturing partners

• Lead vendor evaluation, selection, and relationship management

• Maintain and improve quality management systems (QMS) in compliance with FDA and ISO 13485 standards

• Support regulatory and quality audits and ensure documentation is accurate and audit-ready

• Drive process improvements to increase efficiency, reduce lead times, and ensure product quality

• Provide operational input into forecasting, budgeting, and strategic planning

Requirements

• 5–15+ years of experience in operations, supply chain, or manufacturing management

• Prior experience in the medical device industry required

• Strong knowledge of FDA regulations and ISO 13485 quality systems

• Proven experience working with overseas manufacturing teams, especially in Asia

• Ability to lead projects and teams across time zones and cultures

• Excellent problem-solving, communication, and organizational skills

• Bachelor’s degree in Operations, Engineering, Supply Chain, or a related field 

What We Offer

• Competitive base salary with performance bonus and equity piece