Sr. Engineer I - Process Engineering

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 $5+ billion in sales, 20,000+ 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.

Job Summary

The Sr Engineer I - Process Engineering position is responsible for providing advanced engineering support to existing product process transfer projects, process improvements/cost reduction activities affecting the form, fit or function of the product, and new product development process and production equipment development requirements in accordance within all TMC processes and procedures.

Job Details/Responsibilities

• Provide engineering support to the design, development, and qualification of products, processes, and process equipment in accordance with TMC QA101 Product Development & Design Controls and in full compliance with all design control, quality, and company regulations and national and international regulatory body requirements. This activity includes, but is not limited to, the understanding of change control, validation, documentation practices, process control, and design control requirements.

• Participate in and provide manufacturability insight and guidance to the design and development of new products to facilitate the development of viable production processes for the products under development.

• Serve as a Process Leader for the development or transfer of production processes. Accountable for the execution of all engineering activities required to develop, implement, and validate processes under development or modification. The Process Leader "owns"" the big picture of the production process and ensures that its overall performance and validation requirements are achieved.

• Actively lead and participate in the performance of formal process validations to ensure their compliance to validation protocols. Ensure all protocols and validation reports are correct and well-written.

• Install production/process equipment and support the conduct of Installation Qualification (IQ), Operational Qualification (OQ), pre-Process Qualification (PQ), and formal PQ validation activities and the documentation of their results.

• As required, serve as a Problem Solver to product and process issues and apply the proper engineering tools and techniques for their resolution and implementation of any required process modifications.

• Participate in and contribute to project team meetings, Design Reviews and other formal project reviews.

• Participate in and provide input to the development of project planning activities to include project cost and schedule estimates and performance requirements definition.

• Prepare and present technical presentations to all levels of personnel in a manner that effectively communicates technical activities in an understandable way to the target audience.

• Performs other job related duties assigned.

Job Responsibilities (continued)

Working Conditions/Physical Requirements

Knowledge, Skills and Abilities (KSA)

• Experience in the development of new manufacturing processes for global Medical Devices or other highly regulated industries in accordance with global regulatory and quality standards and requirements.

• Experience in the application of Design for Manufacturability (DFM); Design for Assembly (DFA), and Lean Six Sigma principles and tools.

• Demonstrated understanding of the cross-functional interactions needed for the development of new products and manufacturing processes, preferably within FDA design control guidelines.

• Demonstrated strong analytical and problem solving skills; ability to solve complex problems and implement solutions or processes.

• Demonstrated ability in the design, development and implementation through production qualification of a new or novel medical device production process.

• Strong communications skills. Demonstrated ability to understand and explain complex engineering problems to non-engineering personnel; the ability to create and deliver presentations to executive management; and the ability to prepare detailed Technical Reports appropriate to send to the FDA.

• Effective use of MS Office Suite.

Qualifications/ Background Experiences

BS in Mechanical, Biomedical, or similar engineering discipline from an accredited university or college with 7 or more years of working experience with increasing responsibility in Product and Process Development in the medical device field.

It is Terumo's policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment.