The ideal candidate will oversee drug-eluding balloons in Irvine, California. Manages, directs, and inspires teams to resolve complex production problems with innovative, thorough, and practical solutions that are driven by data. Exercises judgment within broadly defined practices and policies in selecting methods and techniques to obtain desired results. Requires a wide application of principles, theories, and concepts in production, planning, manufacturing engineering, purchasing, and supply chain, plus a working knowledge of combination products. This includes investigating and resolving any ongoing production issues, adapting to a limited supply of materials, and validating new materials for class III medical devices. Drives strategy and implementation for all manufacturing projects, including line moves, capacity increases, and conversion to a pull-driven planning system.

Key Responsibilities:

• Directs plant operations through the development and implementation of world-class policies and procedures.
• Ensures all Operations departments such as facilities, supply chain, planning, production, and manufacturing engineering understand accountabilities through the establishment of department goals based on the business plan.
• Defines, initiates, and executes projects to improve short-term and long-term operations as appropriate.
• Tracks efficiency of Operations processes and adjusts schedules, resources, or procedures as needed to achieve business goals.
• Makes decisions based on understanding multiple departments and the relationship between them.
• Maintains strong relationships with R&D, Quality, Regulatory, Human Resources, Finance, Marketing, and Clinical departments and ensures cross-functional alignment on Operations initiatives.
• Fully understands the precepts of the Quality System Regulations (QSR) and Code of Federal Regulations (CFR) Title 21, Part 4, and ensures compliance with combination product regulations.f
• Oversees implementation of corrective actions for inadequacies in process execution.
• Develops and ensures compliance with guidelines related to health, safety, and environmental practices. Ensures all the required resources are available and in good condition to achieve the Health and Safety objectives.
• Compiles data and prepares plant compliance records.
• Review training programs to ensure alignment with quality and business policies.
• Develops and implements standard operational and working practices.
• Prepares and manages the plant's operational budget.
• Implements effective cost control practices.
• Coaches, mentors, and provides developmental opportunities to staff.
• Evaluate performance and initiate corrective action when necessary.
• Ensures the right level of staffing and competencies are in place for all operations departments.
• Passionate about recruiting and developing a high-powered, diverse Operations team.
• Direct reports include the leads for production, manufacturing engineering, facilities, purchasing, and environmental health & safety.
• Responsible for developing subordinates and encouraging them to use their full potential.

KNOWLEDGE, SKILLS, ABILITIES, AND CERTIFICATIONS/LICENSES REQUIREMENTS:

• Bachelor’s degree in engineering or applied science. Master's degree preferred.
• 10 years of experience in Operations, Manufacturing, or related activities, preferably in medical devices or the pharmaceutical industry, with 3 years at management levels preferred.
• Experience with operations scale-up, new product launches, combination products, quality systems, drug regulations, good manufacturing processes, safety and environment, finance, and human resources.
• Commitment to building culture and driving behavior that’s aligned with company values
• Visionary leadership that inspires teammates to strive for stretch goals
• Strong verbal and written communication skills; comfort speaking in front of large groups
• Ability to translate corporate goals and objectives into successful functional strategies
• Strong ability to analyze and solve problems
• Command of Lean principles and good manufacturing practices
• Ability to perform financial analysis, develop budgets, and implement spend management
• Respond effectively to teammate concerns and complaints
• Ability to effectively manage conflicts and the ability to resolve them diplomatically
• Strong computer skills and command of Microsoft Office tools (Outlook, PowerPoint, Excel, Word)