Engineer 3 - Global Supplier Quality (Tooling & Transfers)

Requisition ID:  31758  

 

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

 

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.

 

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential. 

Terumo Blood and Cell Technologies is hiring a Supplier Engineer to join our Supplier Engineering team within the Global Quality department, supporting projects for multiple sites including Terumo BCT Littleton. This team is responsible for managing supplier tooling and transfer projects to assure high-quality, cost-effective, and on-time delivery of components to our global factories.

Our medical devices enable therapies that help patients all over the world. In this role, you’ll have an impact on patients’ lives by helping to ensure the quality of our devices, like the Rika® and Trima Accel®. From a career growth and development perspective, this is an opportunity to make your mark in our Quality organization through supplier process improvements, equipment upgrades, efficiency improvements, and alleviating pain points in the supply chain and manufacturing.

 

ESSENTIAL DUTIES

• Leads cross-functional supplier projects including new tooling, capacity expansion, and supplier transfers.
• Management of projects including tracking of project scope, schedule, and budget.
• Areas of concentration include injection molding, extrusion, and thermoforming for blood-contacting, disposable products as well as OEM components.
• Management of supplier process validations (IQ/OQ/PQ) and Terumo BCT verification activities (Technical Reviews & Design Verification).
• Creating/modifying technical documents such as protocols, reports, specifications, drawings, and vendor documentation.
• Performing statistical analysis including process capability, equivalency, and measurement system analysis (Test Method Validation).
• Supporting Engineering Change Notices (ECNs).
• Managing additions and changes to the Approved Supplier List and monitoring supplier quality performance.
• Supports relationships with key suppliers by working collaboratively to resolve technical issues and concerns.
• Implements and understands FDA or regulatory requirements as necessary.
• Follows technical specification requirements and provides feedback on various technical processes and procedures.

 

Gain Experience and Make an Impact:

• Opportunity to travel between countries to visit suppliers and Terumo Blood and Cell Technologies sites (travel needs will vary and may range from 10% - 20%).
• Reduce scrap, freight, and part costs by partnering with local suppliers and eliminating inefficiencies.
• Alleviate disruptions in the supply chain and manufacturing process by improving the quality and availability of components we receive from suppliers.

 

MINIMUM QUALIFICATION REQUIREMENTS
Education
Bachelor’s degree in engineering (Mechanical, Industrial, or Biomedical preferred).

 

Experience
Minimum 5 years of experience working with manufacturing processes and a focus on quality.

 

Skills

• Possesses and applies technical engineering knowledge. Must understand the fundamentals of mechanical engineering, common manufacturing methods, and design for manufacturability.
• Ability to solve technical problems and address issues through corrective actions.
• Skilled in communicating complicated concepts in a clear, succinct, and simple manner.
• Proactive in asking questions and sharing updates with the team.
• Organized and able to manage multiple projects at once.
• Continuous improvement mindset, e.g. LEAN, Six Sigma.
• Project management proficiency.

 

-Or-
An equivalent competency level acquired through a variation of these qualifications may be considered.

 

PHYSICAL REQUIREMENTS

General Labor Environment requirements include use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanize