Industrial Engineer II - TPR

Terumo•Caguas, PR

18d•Onsite

About The Position

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 in a regulated medical device manufacturing environment. Ensures 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. The role supports manufacturing performance and continuous improvement through production analysis, engineering project leadership, process standardization, and collaboration with Operations, Quality, R&D, Supply Chain, suppliers, and other stakeholders. The incumbent must follow established Environmental Health & Safety and Quality System policies, programs, rules, and practices, including requirements related to product and patient safety, associate health and safety, and the environment and community.

Requirements

Bachelor’s degree in Industrial Engineering or a related engineering discipline from an accredited institution.
At least six years of progressively responsible experience in industrial engineering, manufacturing engineering, operational excellence, or a related field.
At least three years of experience supporting a regulated manufacturing environment, such as medical device, pharmaceutical, or biotechnology manufacturing.
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.
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 in regulated industries and 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.
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 to communicate technical information and business implications to different 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 industrial engineering tools such as AutoCAD, Minitab, and Visio.
Professional proficiency in English and Spanish.
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.

Nice To Haves

Professional certification or formal training in continuous improvement, statistical analysis, or project management is preferred.

Responsibilities

Analyze production workflows, conduct time and motion studies, and apply Lean, Six Sigma, statistical process control, and root cause analysis to improve safety, quality, productivity, labor utilization, cycle time, and cost performance.
Provide engineering support to resolve process-related issues, optimize production lines and equipment, monitor key performance indicators, and implement corrective actions to minimize downtime and sustain operating targets.
Partner with Quality and Operations to establish and maintain process controls, investigate nonconformances, implement effective corrective and preventive actions, and ensure compliance with approved procedures and applicable quality and regulatory requirements.
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.
Collect, validate, and analyze production data using statistical and engineering tools to identify trends, prioritize opportunities, evaluate improvement results, and communicate recommendations through reports and presentations.
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.
Develop and maintain process documentation, procedures, work instructions, and training materials; deliver continuous improvement training, provide technical guidance and mentoring, and collaborate with stakeholders to sustain standardized practices and organizational results.
Perform other related duties as assigned.
Follow established Environmental Health & Safety and Quality System policies, programs, rules, and practices, including requirements related to product and patient safety, associate health and safety, and the environment and community.