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.

www.terumoaortic.com

This job description has been designed to indicate the general nature and level of work performed by associates within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

Position Summary

Provide Engineering support to improve quality and efficiency for existing components.

Determine critical components and supplier changes to support business needs.

Support key process items to bring new components through the design phase into efficient manufacturing operations.

· 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 of 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

5+ 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

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.