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Engineer II - Process Engineering

Date: Nov 30, 2024

Req ID: 3752

Location:

Elkton, MD, US

Company: Terumo Medical Corporation

Department: TIS Design Assurance/Quality 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 $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 at Terumo. We 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 Engineer II Process Engineering position is a mid-level engineering position responsible for providing 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. Salary range: $74,100 - $111,100

Job Details/Responsibilities

1. Working independently or under the guidance of a senior engineer, perform new process development and production process transfer activities as part of a project team in accordance with QA101 Product Development Process & Design Controls and all other applicable TMC processes and procedures.

2. Execute the design and development of production equipment; to include development of equipment concepts, engineering analysis; conduct of Design of Experiments (DOE), 3-D modeling and analysis; preparation of engineering drawings, equipment and process control documents.

3. Execute the development and build of production processes for and the fabrication of new product prototypes and design verification units.

4. Research and identify vendors, order, and receive components and equipment needed for process development activities.

5. 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.

6. Prepare presentations and present work to project team personnel and senior management.

7. Performs other job related duties assigned.

Knowledge, Skills and Abilities (KSA)

o Positive attitude and ability to learn and work in a project team environment.

o 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.

o Working knowledge of and ability to perform 2D drafting and 3D modeling and analysis

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

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

o Developing analytical and problem solving skills; ability to solve complex problems and implement solutions or processes.

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

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

o Effective use of MS Office Suite.

Qualifications/ Background Experiences

• BS in Mechanical, Biomedical, or similar engineering discipline from an accredited university or college with 3-7 years of working experience.

• Six Sigma Green or Black Belt certification is desirable.

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.