Director of Operations

TekPro

Billerica, Massachusetts

JOB DETAILS
SKILLS
Budgeting, Clinical Outcomes, Contract Manufacturing, Cross-Functional, Documentation, FDA (Food and Drug Administration), FDA Requirements, Forecasting, Healthcare Quality, ISO (International Organization for Standardization), Inventory Management, Leadership, Logistics Management, Manufacturing, Manufacturing Management, Manufacturing Systems, Medical Equipment, Operational Strategy, Operations Management, Organizational Skills, Patient Care, Problem Solving Skills, Process Improvement, Production Control, Production Planning, Purchasing/Procurement, Quality Assurance, Quality Management, Regulations, Relationship Management, Sales Management, Strategic Planning, Supply Chain, Supply Chain Management, Supply Chain Operations, Team Lead/Manager, Team Player, Time Management, Vendor/Supplier Evaluation, Vendor/Supplier Planning, Vendor/Supplier Quality Management, Vendor/Supplier Selection, Wound Care
LOCATION
Billerica, Massachusetts
POSTED
30+ days ago

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 

About the Company

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TekPro