Sr. Engineer II, 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


Job Summary


The Senior Engineer II, Process Development (NPI) is an intermediate expert level role who independently leads significant technical projects and serves as a key contributor to major process development initiatives within New Product Introduction (NPI). This role involves applying advanced knowledge 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 II provides technical leadership within NPI project teams, mentors junior engineers, and plays a vital role in ensuring technical quality and successful implementation for new product launches.


Job Details/Responsibilities


Technical Leadership:

• Independently for mid-scale projects designs, develops, integrates, and validates new or modified manufacturing processes to support New Product Introduction (NPI) in compliance with TMC Quality System requirements and regulatory standards.
• Applies extensive technical knowledge and experience to lead complex process developments design and validation efforts. Possesses deep expertise in Design for Manufacturability (DFM), Design for Assembly (DFA) and equipment specification in new product introduction processes.
• Participate R&D and Design Engineering teams during early product development in the identification, evaluation, and implementation of new process technologies and equipment to improve OEE and reduce manufacturing cost.
• Leads the identification and documentation of critical process parameters (CPPs), material specifications, and equipment needs for NPI projects.
• Solve complex technical challenges encountered during NPI and scale-up.
• Provides technical leadership and mentorship to junior engineers and project teams within NPI projects.

Process Development and Innovation

• Enforce Manufacturing Process Design standards.
• Apply Design For Manufacturability (DFM), Design for Assembly (DFA) and equipment specification in new product introduction processes.
• Contributes to the development of new process technologies for NPI projects, considering factors like OEE and manufacturing cost.
• Lead execution of proof-of-concept for manufacturing methods for NPI.
• Lead 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.
• Develop and lead 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.
• Lead the technical execution acquisition and commissioning of new equipment and tooling required for new products, including test and measurement equipment, and lead their installation and validation.
• May contribute to the assessment of Patent Situation Statements and intellectual property strategy related to manufacturing processes for new products.
• Apply knowledge of industry's common business transaction systems (e.g., SAP, MES, Change Control, Ariba)
• Lead improvements activities using Lean and Six Sigma methodologies applied to NPI processes.

Project Planning and Execution:

• Manages all technical aspects of assigned projects, including planning, execution, and reporting, often overseeing the work of less experienced…