Senior Process Engineer (United States)

Overview

When you join the team at Cordis, you become part of an inspiring mission to save lives, impacting millions of people and broadening access to life-saving cardiovascular and endovascular technology. As a global leader for over 60 years, we are dedicated to being the heart of innovation to transform cardiovascular care.

At Cordis, we're teammates, not just employees. We embrace an empowered and one-team culture where teammates are inspired to unleash their full potential. With diverse teams on a global scale, we believe the richness of our experiences and backgrounds enhances the careers of our teammates, the service to our customers, and ultimately, the lives of our patients.

If you love a challenge and are ready to have a direct, transformative and positive impact on the lives of millions, then Cordis is just the place for you.

We are the people behind the people who keep saving lives.

Responsibilities

Job Summary and Responsibilities

The Sr Process Engineer is responsible for development and implementation of new and optimized manufacturing processes, equipment, test, and inspection procedures. This individual is responsible for identifying and leading projects that improve quality, increase capacity and efficiency. This role involves driving technical excellence, mentoring junior engineers, and ensuring product quality, reliability, and manufacturability throughout the product lifecycle.

• Lead and manage projects to improve existing manufacturing processes, implement new technologies, and support new product introductions.
• Develop, document, and implement new or improved manufacturing procedures and work instructions.
• Plan, write, and execute process and equipment validation protocols (IQ/OQ/PQ).
• Investigate and disposition Non-Conformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs).
• Design and perform experiments, including Design of Experiments (DOE), to characterize, optimize, and improve process performance.
• Provide technical guidance, mentorship, and leadership to junior engineers and technicians.
• May supervise one or more engineers or technicians as required.
• Collaborate daily with assemblers, production supervisors, engineers, and management to ensure process efficiency and compliance.
• Partner with suppliers and external resources to develop, qualify, and implement new processes or equipment.
• Work closely with R&D and Manufacturing teams to interpret design intent and translate it into robust, scalable production processes.
• Foster clear, effective communication across all project and operational stakeholders.
• Identify and communicate business-related issues, risks, or opportunities to management in a timely manner.
• Ensure compliance with all Company Health, Safety, and Environmental (HSE) policies, and verify that necessary resources and equipment are available and in good condition.
• Maintain compliance with all applicable Federal, State, local, and Company regulations, including Quality System and regulatory requirements for relevant markets.
• Perform other related duties and responsibilities as assigned.
  
  
  

Qualifications

Required Qualifications

• Bachelor’s degree in Mechanical, Biomedical, Electrical or related Engineering discipline with minimum of 5 years of relevant experience, preferably in a medical device environment.
• Proven track record working within ISO 13485 and FDA-regulated environments.
• Experience with risk management (ISO 14971), design controls, and documentation practices.
  
  
  

Preferred Qualifications

• Work includes potential exposure to human bloodborne pathogens or other potentially infectious materials.
• Work includes potential exposure to radiation sources such as fluoroscope in a catheter laboratory setting.
• Work includes potential exposure to chemicals.
• Excellent written and verbal communication and interpersonal skills
• Must have the ability to manage work to meet tight timelines and budgetary guidelines
  
  
  

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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.