Manufacturing Engineer I (TAS)

Terumo•Davie, FL

About The Position

The Manufacturing Engineer I supports the manufacturing engineering team, including work related to updating and implementing SAP/HANA. The role develops and implements processes, tools, and gauges; pursues cost reductions; develops process layouts; maintains manufacturing instructions and device history records; and executes process validation protocols, builds, and reports. The engineer works with engineering leadership and cross-functional teams to refine and implement manufacturing processes, transfer new designs into manufacturing, investigate process and quality issues, and lead improvement projects. The role also supports quality-system compliance, audit readiness, and environmental health and safety requirements.

Requirements

Bachelor’s degree in engineering or equivalent experience.
At least 3 years of experience in a technical role in the medical device industry.
Project management experience in the medical device industry.
Hands-on knowledge of electronics, motion control, plastics, metallurgy, and manufacturing processes.
Experience with polymers, medical-grade metals, and medical packaging.
Knowledge of QMS and design-control requirements relevant to the engineering area.
Effective cross-functional communication and collaboration skills, including the ability to prepare and deliver technical presentations to senior management.
Ability to apply statistics to experiments, analyses, and validations.
Ability to solve complex product and process problems, lead improvement opportunities, and guide engineering-team execution.

Responsibilities

Work with the engineering manager or designee to determine projects and related tasks.
Refine manufacturing processes and flow.
Develop new processes that increase productivity and reduce cost.
Implement cost reductions through materials or manufacturing time.
Investigate and provide engineering support for manufacturing processes, statistical process control (SPC), and non-conforming material (NCR).
Prepare, analyze, and present data at monthly NCR and Management Review meetings, if applicable.
Manage the tooling system, including preventive maintenance, calibrations, and equipment records, if applicable.
Manage duties, workload, and personal issues of engineers, technicians, or interns, if applicable.
Complete investigations, improvements, and documentation of preventive and corrective actions (CAPAs).
Apply Lean Manufacturing principles to increase productivity and throughput, reduce cost, and/or eliminate waste.
Implement new processes and issue process validation protocols and reports.
Develop, document using AutoCAD or SolidWorks, and implement fixtures, jigs, tools, and gauges.
Document manufacturing and inspection methods in Manufacturing Instructions.
Work with Research and Development and Process Development to develop and transfer new designs to manufacturing, including leading and managing design-transfer projects.
Initiate process, design, and documentation changes through the change-management process.
Use statistics to evaluate, justify, and support experiments, analyses, and validations.
Record engineering evaluations in Engineering Notebooks.
Perform tooling verifications and IQ/OQ/PQ activities.
Perform root-cause investigations and develop and implement solutions.
Perform process development and execute Design of Experiments (DOEs).
Work with the Manufacturing Supervisor to analyze manufacturing data and lead resulting improvement projects.
Maintain awareness of how work contributes to quality objectives; follow the QMS, complete records accurately, and promptly raise quality issues to the immediate supervisor.
Ensure the facility, processes, and documentation remain audit-ready.
Take responsibility for personal health and safety and that of others affected by work, and cooperate in raising Environmental Health and Safety issues.
Apply engineering expertise and business understanding; communicate and collaborate effectively across functions; support customers; develop self and others; drive innovation and improvement; and deliver assigned work and project results.