Intuvie has a track record of bringing impactful innovations to the healthcare industry – namely in the area of infusion therapies. We provide both large volume and ambulatory infusion pumps, as well as connectivity software that improves clinician productivity. At Intuvie, our mission is to deliver both simplicity and control of infusions through ease of use, portability, affordability, and safety-driven designs that can be used by patients and clinicians alike.
Senior Director, Operations
Responsibilities:
Achieves local, onsite operational goals including productivity, quality, cost, delivery, safety and colleague engagement requirements while maintaining strict adherence 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 safety, production, performance, and quality standards are consistently met.
Reviews operations, servicing, maintenance and distribution reports to ensure safety, quality, financial, and delivery goals and standards are met.
Develops and implements 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 effectively grow the organization for financial and operational efficiencies.
Assists VPs of Engineering, Sales and Finance with long-range operating goals, expansion efforts, and implementation of new and advanced technology/products.
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 and 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 Finance Team to develop 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
Skills/knowledge/abilities:
Excellent verbal and written communication skills
Excellent organizational and managerial skills
Ability to set long-term goals and communicate them to others
Ability to motivate and organize multiple efforts to accomplish goals
Education and/or Experience:
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
Experience in the medical device industry is a requirement
Strong understanding of manufacturing processes, quality management, and continuous improvement methodologies (e.g., Lean, Six Sigma)
Excellent leadership, team-building, and communication