Senior Process Engineer II

Job Summary

At Terumo Cardiovascular, we develop, manufacture and distribute medical devices for cardiac and vascular surgery. 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. We do this by providing lifesaving technology to cardiac surgery teams around the world.

Responsibilities

• 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.
• Utilizes 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, thus allowing the organization to meet business needs.
• Perform other duties as assigned.

Qualifications

• 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.
• The annualized base salary range for this role is $105,060.00 to $139,587.00. Final compensation packages will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand.
• Terumo Cardiovascular is an equal opportunity employer. We promote recognition and respect for individual and cultural differences, and we work to make our employees feel valued and appreciated, whatever their race, gender, sex, sexual orientation, gender identity and/or expression, and genetic information.