Senior Process Engineer II

Join to apply for the Senior Process Engineer II role at Terumo Cardiovascular

At Terumo Cardiovascular, we develop, manufacture and distribute medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass, intra‑operative monitoring and vascular grafting. Our mission is to work as a team to save one more life, today and every day. We do this by providing lifesaving technology to cardiac surgery teams around the world.

At Terumo we’re working to build a healthier, happier society for our associates and the world. Our story begins over 100 years ago in Japan and has since united us around our mission to contribute to society through healthcare. As an associate at Terumo, your work helps to shape our evolution for the future by learning, innovating and challenging ourselves to write the future of healthcare.

This position is responsible for leading strategic initiatives and cross‑functional programs to optimize manufacturing operations. The role will drive innovation, efficiency and scalability, focusing heavily on equipment design, build and deployment to ensure robust, compliant and cost‑effective production.

• Demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures.
• Lead the design, build and commissioning of custom manufacturing equipment and automation systems for medical device production.
• Collaborate with R&D, Quality and Operations to translate product requirements into scalable manufacturing solutions.
• Develop and optimize process flows, equipment specifications and validation protocols (IQ/OQ/PQ).
• Drive continuous improvement initiatives using Lean, Six Sigma and other methodologies to enhance throughput, yield and reliability.
• Manage capital projects, including vendor selection and coordination, budget control and timeline adherence.
• Ensure all equipment and processes comply with FDA, ISO 13485 and other applicable regulatory standards.
• Support root cause analysis and corrective actions for process deviations and equipment failures.
• Maintain documentation and traceability for all engineering activities, including design history files and risk assessments.
• Utilize the systems and processes in place to attract, develop, engage, train and retain talented associates, creating a work environment where associates can realize their full potential.
• Perform other duties as assigned.

Requires a bachelor’s or master’s degree in Mechanical, Electrical or Industrial Engineering and a minimum of eight years of experience in equipment design and process engineering, preferably in the medical device industry.

• 401(k) with 6% matching
• Paid time off
• Company paid holidays
• Medical, dental, vision insurance
• Flexible spending account
• Health savings account
• Company paid life insurance
• Employee assistance program
• Parental leave
• Tuition reimbursement

Mid‑Senior level

Full‑time