Director of Operations, Selution (Irvine, CA)

Overview

Cordis is a pioneering medical technology company specializing in groundbreaking solutions for cardiovascular and peripheral vascular diseases. Our flagship product, SELUTION, combines pharmaceuticals with a traditional balloon catheter, revolutionizing treatments for coronary and peripheral artery diseases. With four Investigational Device Exemptions (IDEs) approved and actively enrolling patients (Coronary ISR, Coronary De Novo, Peripheral SFA, and Peripheral BTK), Cordis is leading the way in delivering transformative medical solutions.

Oversees manufacturing of Cordis 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, supply chain plus a working knowledge of combination products. This includes investigation and resolution of any ongoing production issues, adaptation to limited supply of materials, and validation of 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.

Responsibilities

• Directs plant operations through 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.
• Oversees implementation of corrective actions for inadequacies in process execution.
• Develops and ensures compliance to 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.
• Reviews training programs to ensure alignment with quality and business policies.
• Develops and implements standard operational and working practices.
• Prepares and manages plant's operational budget.
• Implements effective cost control practices.
• Coaches, mentors and provides developmental opportunities to staff.
• Proactively manages site and team culture to align with Cordis POWER values.
• Evaluates performance and initiates corrective action when necessary.
• Ensures the right level of staffing and competencies for are in place for all operations departments.
• Passionate about recruiting and developing a high-powered, diverse Operations team.
  
  
  

Supervisory Responsibilities

• 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.
  
  
  

Qualifications

• Batchelor’s degree in engineering or applied science. Master's degree preferred.
• 10+ years of experience in Operations, Manufacturing, or related activities, preferably in the field of 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.
  
  
  

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

• 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)
  
  
  

Pay / Compensation

The expected pre-tax pay rate for this position is $169,700 – $242,550

Actual pay may fluctuate outside of the listed range depending on skills, education, experience, job-related knowledge and location.

US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa.

Why Join Cordis?

For more than 60 years, we have been building interventional vascular technology that offers higher quality and less invasive experiences for people around the world. With a global reach and vast network of resources, we empower you to do your best work and unleash your full potential. Do you want to grow your career surrounded by a supportive team of subject matter experts? Then join us and let’s improve the wellbeing of millions, together.

Cordis is proud to be an equal opportunity employer and is committed to providing equal opportunity for all teammates and applicants. At Cordis, our teammates all bring different strengths, experiences, and backgrounds, who share a passion for improving people's lives. Diversity not only includes race and gender identity, but also age, disability status, veteran status, sexual orientation, religion, and many other parts of one’s identity. All our teammate’s points of view are key to our success, and we believe inclusion is everyone's responsibility. Together, we strive to create and maintain working and learning environments that are inclusive, equitable and welcoming.