Program Manager, R&D - Selution (Irvine, CA) - Cordis

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.

SELUTION is poised for accelerated growth and preparing for vertical integration to support the US and global launch of four Investigational Devices. As a Program Manager at Cordis, you will assume a pivotal role in leading cross-functional teams to achieve these goals. Your primary responsibility will involve guiding teams in executing operational initiatives in preparation for approvals and launches in the US and worldwide, driving innovation within the medical technology sector.

• Strategic Project Management: Provide strategic oversight and guidance to the cross functional team, ensuring meticulous maintenance of project Gantt charts, identification of critical paths, and proposing effective solutions to address potential roadblocks.
• Cross-Functional Team Leadership: Lead cross-functional team meetings to foster effective communication and collaboration among team members, promoting a cohesive and efficient working environment.
• Risk Mitigation: Oversee the risk register, proactively identifying and addressing potential issues that may impact project timelines and objectives, ensuring a proactive and strategic approach to risk management.
• Task Tracking and Milestone Management: Supervise project tasks, ensuring milestones are met, and project objectives are achieved within specified timelines.
• Budgetary Oversight: Take ownership of the program budget, demonstrating adept management skills to ensure projects are executed within financial constraints.
• Regulatory Documentation Management: Maintain records, ensuring accuracy, completeness, and compliance with company and regulatory standards for all project documentation.
• Communication and Reporting: Responsible for maintaining high-level program dashboards, providing regular report-outs to Senior Leadership, and disseminating program updates throughout the organization.

• Educational Background: College degree in engineering or related field.
• Regulatory Mastery: Mastery of FDA-mandated design controls (21 CFR 820).
• Experience: 5+ years of experience in the medical device or related industry, with a proven track record of managing successful programs.

Skills and Qualities:
• Analytical and Problem-Solving Skills: Strong analytical and problem-solving capabilities.
• Organizational Skills: Excellent organizational and time management abilities.
• Communication: Effective communication and interpersonal skills.
• Proactivity: Proactive and detail-oriented approach to program management.
• Collaborative Team Player: Ability to work collaboratively in a cross-functional team.
• Regulatory Knowledge: In-depth knowledge of medical device industry regulations and quality standards.
• Technology Proficiency: Proficiency in project management software and tools.

Benefits:
• Competitive Compensation: Competitive salary and benefits package.
• Professional Growth: Opportunities for professional growth and development.
• Cutting-Edge Technology: Access to cutting-edge medical technology and innovations.
• Dynamic Work Environment: A collaborative and dynamic work environment.

If you are a highly motivated and organized individual with experience in Program Management and a passion for advancing medical technology, we invite you to join the Cordis team. Be a part of our mission to make a meaningful difference in the lives of patients worldwide through the innovative SELUTION program.

Pay / Compensation
The expected pre-tax pay rate for this position is $107,800 – $154,000
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.