Process Engineer
4 weeks ago
Job Summary
The Engineer II Process Engineering position is a mid-level engineering role 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 with all TMC processes and procedures.
Key Responsibilities
- 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.
- 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.
- Execute the development and build of production processes for and the fabrication of new product prototypes and design verification units.
- Research and identify vendors, order, and receive components and equipment needed for process development activities.
- 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.
- Prepare presentations and present work to project team personnel and senior management.
Requirements
- Positive attitude and ability to learn and work in a project team environment.
- 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.
- Working knowledge of and ability to perform 2D drafting and 3-D modeling and analysis.
- Understanding of the application of Design for Manufacturability (DFM); Design for Assembly (DFA), and Lean Six Sigma principles and tools.
- Developing understanding of the cross-functional interactions needed for the development of new products and manufacturing processes, preferably within FDA design control guidelines.
- Developing 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.
- Effective use of MS Office Suite.
Qualifications
- 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.
Terumo Medical Corporation is an equal opportunity employer and welcomes applications from diverse candidates. 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.
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