Sr. Engineer Sustaining Engineer

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 Summary

Identify supplier efficiencies and develop improvements to ensure quality, cost, and efficiency requirements. Support activities related to critical components and supplier changes. Performs new product development activities, product evaluation and testing, support process development, test fixture development, and verification/validation protocol and reports.

Key Accountabilities:

• Lead and manage component qualification activities for existing components into efficient manufacturing operations.
• Lead the Sustaining Engineering team to successfully build, maintain, and innovate high-quality components that provide solutions that meet production demands.
• Review product/component performance to identify trends and develop appropriate component improvements.
• Emphasis on a functional specialty within the department. This may be associated with innovation, design control, etc. as a subject matter expert.
• Develop, test, and refine prototypes and new product designs.
• Finalize designs and create detailed engineering specifications ensuring proper tolerancing and design for manufacturability
• Develop verification/validation protocols, carry out testing and write reports.
• Lead portions of new product development projects or major design change projects.
• Manage product builds for formal testing programs
• Assure Design Development processes are in accordance with design control procedures
• Develop project timeline for development projects and ensure project execution.
• Develop and implement new processes, test fixtures, and documentation methods.
• Work with Regulatory/ Quality group to carry out functionally specific testing.
• Take part in design reviews and technical product reviews.
• Work with Directors and managers to carry out project tasks.
• Investigate field product complaints and develop and implement improvements.
• Supervise technicians and/or lower-level engineers.

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:

• Ability to organize and conduct experiments independently
• Ability to analyze and solve technical problems
• Good oral and written communication skills (English)
• Work well in a team environment

Minimum Knowledge & Experience required for the position:

• 4 – year engineering degree
• Hands-on Experience building prototypes, tooling, test fixtures
• Understanding of quality system requirements (e.g. 21CFR820, ISO13485).
• 6 years of experience in Catheter or Endovascular device development experience
• 6 years of experience as an engineer in the medical device industry
• Hands-on Experience building prototypes, developing in-vitro testing, capturing the output of in-vitro and in-vivo testing, developing of tooling and test fixtures
• Proficient skills in design software (Solid Works, AutoCAD, or Pro-E)
• Proficient in statistical methods and associated software
• Hands-on knowledge of plastics, metallurgy, and manufacturing processes
• Detailed knowledge of Design and Controls per ISO13485