Hiring: Process Development Engineer I Company: Terumo Aortic Location: Sunrise, FL Job Posted Time: 2026-09-10 13:44:15 Target Skills & Keywords : Assembly, AutoCAD, CAD, Change Management, Lean Manufacturing, Project Management, Six Sigma, SolidWorks About the job Experience: •Must work well under pressure. •Knowledge of AutoCAD and SolidWorks or other CAD modelling software. •Knowledge of engineering statistics and data analysis •Technical writing skills for manufacturing instructions, test methods, protocols, reports, etc., is a must. •Able to work closely with a variety of people and teams within the company. Required Skills: •Design, evaluate, implement, and monitor processes and operating systems for the manufacture aortic stent grafts. •Develop and implement new mfg. processes, execute process validations such as IQ, OQ, PQ protocols and reports. •Lead the design transfer phase including product development, validation planning, design for manufacturability and assembly, Design of Experiments, process capability analysis, etc. •Conduct risk analysis including DFMEA, PFMEA and create/maintain necessary documentation. •Actively facilitate and support conversion of small-scale processes into commercially viable large-scale operations. •Monitor and improve the efficiency, output, and safety of manufacturing processes through observations and measurements as well as by collecting and interpreting data from other technical and operating personnel. •Design tooling and fixtures that will be used for the manufacturing and assembly of products. •Log evaluations into Engineering Notebooks Qualifications: •Must work within requirements of company handbook and policy statements. •Note: Company Handbook, Policy Statement and Authorization of Limits do not form part of the quality system •Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives. •Work within the QMS always, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality. •Responsible to ensure facility, processes and documentation always remain in a state of audit readiness. •Take care of your own health and safety and that of others who may be affected by your actions. •Work co-operatively to highlight issues affecting Environmental Health and Safety Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!