Senior Process Engineer II

About the Company

Terumo Cardiovascular develops, manufactures, and distributes medical devices for cardiac and vascular surgery with an emphasis on cardiopulmonary bypass, intra-operative monitoring, and vascular grafting. This includes a full line of perfusion products, endoscopic vessel harvesting products, and surgical stabilization products. Our mission is to work as a team to save one more life, today and every day, 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 began over 100 years ago in Japan, united by our mission to contribute to society through healthcare. As an associate, your work helps shape our evolution for the future through learning, innovating, and challenging ourselves to write the future of healthcare.

About the Role

The Senior Process Engineer II leads the development, improvement, and deployment of manual and semi-automated manufacturing processes within a regulated production environment. This highly hands-on role requires strong technical expertise in equipment design, PLC/HMI controls, process characterization, tooling and fixture development, and production line integration. The engineer is responsible for establishing and scaling robust, efficient, and compliant processes by developing or upgrading equipment, supporting process validations, improving process capability, and leading root-cause investigations.

Responsibilities

• In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to 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 systems and processes 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.

Requirements

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.

Benefits

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