Associate Sustaining Engineer - job 2 of 2

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

Position Summary

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

Assists in determining critical component(s) and supplier changes to support business needs.

Key Accountabilities:

• 
  Helps in working with key suppliers to identify and develop improvements to ensure quality and cost requirements.
• Assists and may lead component qualification activities and improvements.
• Helps in developing fixtures, jigs and gages to assist with component inspection processes.
• Documents methods for inspection processes; assists in TMV activities.
• Log evaluations into Engineering Notebooks
• Assists in the design, evaluation, implementation, monitoring and operating systems for the manufacture of aortic stent grafts and delivery systems.
• Helps to develop and implement new Mfg. processes, execute process validations such as IQ, OQ, PQ protocols and reports.
• Conducts risk analysis including DFMEA, PFMEA and create/maintain necessary documentation.
• Supports the conversion of small-scale processes into commercially viable large-scale operations.
• Works with Research and Development to develop and transfer new component designs to manufacturing.
• Perform statistical analyses on data groups.
• Presents data and projects to upper management when required.
• Helps perform TMV and software validation activities as necessary.
• Monitors and helps 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.
• Supports 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:

• Bachelor’s degree in engineering or a 2 - year technical degree with equivalent experience
  • Experience in a technical role within the medical device industry preferred.

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.