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Engineer I Sustaining Engineer

Company: Terumo Aortic
Location: Dania
Posted on: January 16, 2022

Job Description:

At Terumo Aortic, our mission is to transform the treatment of aortic disease worldwide. With our comprehensive portfolio of surgical, endovascular and hybrid technologies, we enable physicians to find the right fit for each patient anatomy.The company has over 1,250 associates around the world with manufacturing facilities in Glasgow, Scotland and Sunrise, Florida.Terumo Aortic is focused on the continuing development of new and innovative products driving the growth of the business globally. Associates are part of a stimulating and exciting environment in which they can develop their skills and achieve career goals. Working for the company, each associate's role contributes greatly to helping to save or improve the lives of patients in over 100 countries worldwide.
Position SummaryProvide Engineering support to improve quality and efficiency for existing components.Determine critical component and supplier changes to support business needs.Support key process items to bring new components through the design phase into efficient manufacturing operations. Key Accountabilities:
- Work with key suppliers to identify and develop improvements to ensure quality and cost requirements - Responsible for component qualification activities and improvements - Develop fixtures, jigs and gages to assist with component inspection processes - Document methods for inspection processes - Log evaluations into Engineering Notebooks - 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 - Conduct risk analysis including DFMEA, PFMEA and create/maintain necessary documentation. - Support the conversion of small-scale processes into commercially viable large-scale operations. - Work with Research and Development to develop and transfer new component designs to manufacturing - Perform statistical analyses on data groups - Present data and projects to upper management when required - Lead TMVs and software validation as necessary - 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. - Support Quality system items such as CAPAs, NCRs, CQPs, TMVs, etc. - Other various responsibilities and projects, as necessary Internal Networking/Key relationships:
This position requires cooperating with different company departments, such as Quality, R&D, Regulatory, Operations, Sales, Marketing, Finance and the other team members of the department
Minimum Skills and Capabilities: - Must work well under pressure - Knowledge of AutoCAD and SolidWorks - Knowledge of engineering statistics - Technical writing skills for manufacturing instructions, test methods, protocols, reports, etc. a must - Able to work closely with a variety of people and teams within the company - Ability to organize and conduct experiments independently - Ability to analyze and solve technical problems - Hands on abilities to engineer tooling, processes, and equipment - Hands on experience building prototypes, tooling, and fixtures - Excellent written and verbal communication skills - Proficient in software applications
Minimum Knowledge & Experience required for the position:

  • 4 - year engineering degree or equivalent experience
  • 3+ years of experience in a technical role in the medical device industry
  • Project management experience in the medical device industry
  • Experience and understanding of quality system regulations (e.g. 21CFR820, ISO13485).
  • Project management experience in the medical device industry
  • Experience with polymers, medical grade metals and medical packaging
  • Hands-on knowledge of electronics, motion control, plastics, metallurgy, and manufacturing processes.

Keywords: Terumo Aortic, Miami , Engineer I Sustaining Engineer, Engineering , Dania, Florida

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