Sustaining Engineer II Job Fairbanks area,Alaska USA,Engineering

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.

At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients.

Join us and help shape wherever we go next!

Advancing healthcare with heart

Job 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.

Job Details/Responsibilities

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

Job Responsibilities (continued) Working Conditions/Physical Requirements Knowledge,

Skills and Abilities

(KSA)

Must work well under pressure.
Knowledge of AutoCAD and Solid Works
Knowledge of engineering statistics
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
Project management experience in the medical device industry
Experience and understanding of…