Industrial Engineer II - TPR

Job description

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come. At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients. Join us and help shape wherever we go next! Advancing healthcare with heart Job Summary Under general supervision, designs, analyzes, and improves integrated manufacturing systems and production processes to enhance safety, quality, capacity, productivity, cost effectiveness, and operational performance. Leads moderately complex continuous improvement and process optimization initiatives, applies data-driven engineering methods, and partners with cross-functional teams to implement sustainable solutions within a regulated medical device manufacturing environment. Ensures that assigned processes and improvements comply with applicable quality, regulatory, environmental, health, and safety requirements while providing technical guidance to operations and less-experienced team members. Job Details/Responsibilities Optimize Manufacturing Processes – Analyze production workflows, conduct time and motion studies, and apply Lean, Six Sigma, statistical process control, and root cause analysis methods to improve safety, quality, productivity, labor utilization, cycle time, and cost performance. Support Production Performance – Provide engineering support to resolve process-related issues, optimize production lines and equipment, monitor key performance indicators, and implement corrective actions that minimize downtime and sustain operating targets. Ensure Quality and Regulatory Compliance – Partner with Quality and Operations to establish and maintain process controls, investigate nonconformances, and implement effective corrective and preventive actions while ensuring compliance with approved procedures and applicable quality and regulatory requirements. Plan Capacity and Facility Layout – Develop capacity analyses and design or improve facility and production layouts to optimize workflow, material handling, space utilization, and readiness for current and future demand; recommend equipment and technology enhancements as appropriate. Analyze Data and Report Performance – Collect, validate, and analyze production data using appropriate statistical and engineering tools to identify trends, prioritize opportunities, evaluate improvement results, and communicate actionable recommendations through reports and presentations. Lead Engineering and Improvement Projects – Plan and execute moderately complex initiatives involving process improvements, facility expansions, technology implementations, and new product introductions; manage scope, timelines, budgets, risks, and cross-functional deliverables to achieve defined business objectives. Standardize Processes and Build Capability – Develop and maintain process documentation, procedures, work instructions, and training materials; deliver continuous improvement training, provide technical guidance and mentoring, and collaborate with Operations, Quality, R&D, Supply Chain, suppliers, and other stakeholders to sustain standardized practices and organizational results. Other related duties may be applied. Incumbent must follow all established Environmental Health & Safety and Quality System policies, programs, rules and practices, including but not limited to product and patient safety, the health and safety of all associates as well as the environment and community at large. Knowledge, Skills and Abilities (KSA) Knowledge Knowledge of industrial engineering principles and practices, including process analysis, workflow optimization, capacity planning, facility layout, labor utilization, and production scheduling. Knowledge of continuous improvement methodologies, including Lean manufacturing, Six Sigma, 5S, waste reduction, root cause analysis, and process standardization. Knowledge of statistical analysis methods, including statistical process control, Pareto analysis, time and motion studies, takt time analysis, and performance trend evaluation. Knowledge of manufacturing operations within regulated industries, preferably medical device, pharmaceutical, or biotechnology manufacturing. Knowledge of applicable quality systems and regulatory requirements, including FDA regulations, ISO standards, environmental health and safety requirements, and internal operating procedures. Knowledge of project management principles, including project scope, timelines, budgets, resource coordination, risk management, and implementation planning. Knowledge of production systems, equipment optimization, material flow, space utilization, and manufacturing technology applications. Skills Strong analytical and problem-solving skills to evaluate production data, identify root causes, assess alternatives, and develop practical recommendations. Proficiency in applying industrial engineering and statistical tools to improve productivity, quality, capacity, safety, cost, and operational performance. Project management skills to plan, coordinate, and execute moderately complex process improvement, facility, technology, and operational initiatives. Effective written, verbal, and presentation skills, with the capability to communicate technical information and business implications to different organizational audiences. Cross-functional collaboration and facilitation skills to align stakeholders, coordinate deliverables, resolve barriers, and support sustainable improvements. Training, coaching, and technical guidance skills to support knowledge transfer, process standardization, and development of less-experienced personnel. Proficiency in Microsoft Office applications, including Excel, Word, PowerPoint, and Project, and in industrial engineering tools such as AutoCAD, Minitab, and Visio. Professional proficiency in English and Spanish. Abilities Ability to independently analyze varied and moderately complex manufacturing problems involving multiple operational, technical, quality, cost, capacity, and regulatory factors. Ability to translate engineering analyses and production data into clear, actionable recommendations that support operational and business decisions. Ability to lead cross-functional projects or workstreams and influence outcomes without direct supervisory authority. Ability to prioritize assignments, manage competing demands, and deliver agreed-upon results under general supervision. Ability to design and implement sustainable process improvements while maintaining compliance with quality, safety, regulatory, and procedural requirements. Ability to evaluate process, equipment, technology, capacity, and layout alternatives and recommend solutions based on operational impact, risk, cost, and expected benefits. Ability to communicate with and influence employees, technical professionals, functional partners, suppliers, and site leadership. Ability to work effectively in a regulated, onsite manufacturing environment and enter controlled areas requiring established gowning and safety practices. Qualifications/ Background Experiences Bachelor’s degree in Industrial Engineering or related engineering discipline from an accredited institution. Minimum of six years of progressively experience in industrial engineering, manufacturing engineering, operational excellence, or a related field, including at least three years supporting a regulated manufacturing environment such as medical device, pharmaceutical, or biotechnology. Demonstrated experience independently analyzing and improving manufacturing processes and leading moderately complex cross-functional initiatives involving productivity, capacity, quality, cost, facility layout, or technology implementation. Professional certification or formal training in continuous improvement, statistical analysis, or project management is preferred. It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program.