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Terumo Medical Corporation Senior Engineer I - Packaging in Elkton, Maryland

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:

This position is responsible for investigating, leading, planning, developing and implementing the more complex packaging / labeling projects in support of new and existing products/processes. Involved with leading projects of varied scope requiring engineering team or cross-functional team effort. Provides support to existing packaging / labeling operations and equipment. This position will be a subject matter expert in packaging design, testing, packaging / labeling equipment, processes, and software for existing operations.

Job Details:

  1. Maintain and follow TMC Quality System requirements; including but not limited to understanding of change control, validation, documentation practices, and design control requirements.

  2. Collaborate and maintain cross-functional partnerships with groups including but not limited to New Product Development Packaging Engineer(s), Quality Engineers, Manufacturing Engineers, and Operations associates/management.

  3. Manage multiple projects simultaneously

  4. Support of existing packaging / labeling processes and equipment.

  5. Plan work schedules, expenditures, attend meetings, coordinate resources and prepare reports as required, ensuring effective communication of ideas, information, and issues to appropriate stakeholders

  6. Capable of leading the design, development and qualification of packaging systems for new and existing products which may include feasibility studies, sealing characterizations, design verification testing and/or justification.

  7. Provide engineering expertise in the design, fabrication, development, installation, validation and qualification of packaging / labeling equipment and software which may include feasibility studies and/or proper documentation for justification of project and training to ensure proper operation of the equipment

  8. Provide technical assistance and leadership in the planning and implementation of packaging / labeling projects to develop, install, and qualify new processes for manufacturing or improving existing processes.

  9. Maintains high awareness of technical trends and developments in the packaging industry.

  10. Assign, delegate and assist in the completion of engineering tasks or projects to lower lever engineers.

  11. May be necessary to coordinate the activities of support groups such as purchasing, scheduling, production, etc. Collecting of data from various sections.

  12. Performs other job-related duties assigned.

Knowledge, Skills and Abilities

  • Excellent knowledge of packaging test methodology

  • Excellent understanding of packaging materials’ capabilities and equipment

  • Excellent knowledge of and experience complying to ISO 11607

  • Thorough understanding of medical device processes and effect on packaging preferred

  • Able to analyze all aspects of package systems

  • Experience in a manufacturing environment for designing, specifying, assembling, and validating packaging / labeling equipment, processes, and software.

  • Excellent analytical and problem solving skills.

  • Thorough knowledge of statistical techniques.

  • Thorough knowledge of equipment and process validations, including development of protocols and execution of protocols.

  • Successful experience leading project teams is preferred.

  • Thorough knowledge of equipment and tools in laboratory testing and inspection systems.

  • Thorough understanding of Performance and Integrity package testing procedures.

  • Knowledge of GMP/FDA regulations preferred.

  • Ability to create and work from engineering drawings.

  • Excellent communication skills both verbal and written.

  • Effective use of MS Office Suite.

Background Experiences

  • BS in packaging, mechanical, or related engineering field with 7 years relevant work experience in packaging specifically in an FDA regulated industry required, or equivalent combination of relevant education and experience

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.

Job Category: R&D

Affirmative Action/Equal Employment Opportunity Statement

It is the Company'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. In compliance with the Americans with Disabilities Act (ADA), if you have a disability and would like to request an accommodation with regard to the application and selection processes (for example, the online application process or interviews) or have any questions about our website accessibility, please call 732-302-4902 or e-mail us at Staffing@Terumomedical.com.

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