Sr. Engineer , Process Development

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation;

one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions:
Terumo Interventional Systems and Terumo Medical Products.

We believe that the future is bright for everyone  work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come.

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

The Senior Engineer I, Process Development (NPI) is an advanced intermediate level role capable of independently managing and executing technical projects of moderate to high complexity within the New Product Introduction (NPI) framework. This role involves applying a strong understanding of Manufacturing Process Strategies, DFM/DFA, Lean, and Six Sigma to design, develop, integrate, and validate robust manufacturing processes into the Value Streams

The Senior Engineer 1 ensures technical quality, contributes to project success, and may provide guidance to junior team members.

• Under minimum guidance designs, develops, integrates, and validates new or modified manufacturing processes in compliance with TMC Quality System requirements and regulatory standards.
• Applies advanced engineering principles and technical knowledge to process developments design and validation efforts. Possess working understanding of Design for Manufacturability (DFM), Design for Assembly (DFA) and equipment specification in new product introduction processes.
• Provides guidance and mentorship to junior engineers and technicians on specific project tasks and methodologies within NPI projects.

• Maintain Manufacturing Process Design standards.
• Contributes to the use of Design For Manufacturability (DFM), Design for Assembly (DFA) and equipment specification in new product introduction processes.
• Contributes to the definition and documentation of critical process parameters (CPPs) and material specifications for new manufacturing processes.
• Contribute to assessing the proof-of-concept for manufacturing methods for NPI.
• Contributes to the execution of laboratory-polit scale processes and prototypes into scalable manufacturing processes by identifying critical process parameters (CPPs), material specifications, and equipment needs at platform level.
• Contribute to the process risk analysis (EFMEA, pFMEA) and execute process development activities including, commissioning (URS/FRS/Traceability Matrix), characterization and validation strategies (IQ/OQ/PQ) in accordance with regulatory and internal standards.
• Execute activities required for the acquisition and commissioning of new equipment and tooling required for new products, including test and measurement equipment, and lead their installation and validation.
• Apply knowledge of industry's common business transaction systems (e.g., SAP, MES, Change Control, Ariba)
• Use Lean and Six Sigma tools applied to NPI processes.
• Project Planning and Execution:
• Manages technical…