Senior Director Operations – Medical Device

Our client is a commercial-stage medical device company dedicated to improving patient outcomes through innovative products. With a focus on excellence and quality, they are at the forefront of the medical device industry, delivering cutting-edge solutions to healthcare providers globally.

Position Overview: We are seeking a highly skilled and experienced Senior Director of Operations to join our client’s dynamic team. In this key leadership role, you will oversee and optimize the manufacturing programs, ensuring the highest operational efficiency and compliance with regulatory requirements. You will lead a team of Operations Managers, fostering a culture of collaboration and continuous improvement to drive the success of our manufacturing operations.

Responsibilities:

• Achieves local, onsite operational goals, including productivity, quality, cost, delivery, safety, and colleague engagement requirements while strictly adhering to FDA and other government and local regulations.
• Responsible for oversight of the Operations Managers and their teams.
• Oversees the external manufacturing, servicing, maintenance, and distribution of class II medical device products, ensuring consistently meeting safety, production, performance, and quality standards.
• Review operations, servicing, maintenance, and distribution reports to ensure safety, quality, financial, and delivery goals and standards are met.
• Develop and implement a risk-based oversight program for all outsourced manufacturing, servicing, and maintenance operations to ensure full compliance with FDA regulations.
• Ensures the proper operational controls, metrics, procedures, and personnel are in place to grow the organization for financial and operational efficiencies effectively.
• Stay abreast of industry trends and best practices in operations management.
• Assists VPs of Engineering, Sales, and Finance with long-range operating goals, expansion efforts, and new and advanced technology/product implementation.
• Develop and execute strategies to maximize production efficiency, reduce waste, and improve overall operational performance.
• Monitor key performance indicators (KPIs) such as CFR, on-time shipment, cycle times etc.; implement corrective actions as necessary to achieve operations goals.
• Lead and support lean manufacturing initiatives, process improvement projects, and the implementation of new technologies to enhance productivity.
• Foster a culture of innovation and creativity in problem-solving.
• Works with the Finance Team to develop an operating budget and ensure cost controls in the manufacturing process.
• Delivers progress and production reports to executive team members as requested.
• Supervises equipment purchase, maintenance, and layout.

Requirements:

• Experience in the medical device industry is required.
• Bachelor’s degree in Manufacturing, Engineering, Business, or a related field (Master’s degree preferred).
• Proven experience in manufacturing leadership roles, with at least 10 years of experience in a similar position
• Proven track record of success in leading and optimizing operations at a senior level.
• In-depth knowledge of key supply chain/logistics processes and best practices.
• Knowledge of Quality Control, Manufacturing Engineering, Purchasing, Planning, Inventory Control, Document Control, Shipping and Receiving, Facilities and maintenance, FDA GMP, and ISO 13485 regulations.
• Strong understanding of manufacturing processes, quality management, and continuous improvement methodologies (e.g., Lean, Six Sigma).
• Excellent leadership, team building, and communication skills.

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