Demo

Engineer II - Packaging

Terumo
Elkton, MD Full Time
POSTED ON 3/4/2025
AVAILABLE BEFORE 5/25/2025

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 :

This position is responsible for investigating, leading, planning, developing and implementing the packaging / labeling projects in support of new products and existing operations. Involved with leading projects of varied scope requiring engineering team or cross-functional team effort. Provides support to existing packaging / labeling operations and equipment.

Job Details :

  • Maintain and follow TMC Quality System requirements; including but not limited to understanding of change control, validation, documentation practices, and design control requirements.
  • Collaborate and maintain cross-functional partnerships with other departments such as Design and Technology, Quality, Regulatory, Marketing, Manufacturing
  • Support multiple projects simultaneously
  • Provide day to day support on existing packaging / labeling processes and equipment
  • Capable of leading and executing packaging / labeling related projects from design through validation
  • Plan work schedules, expenditures, attend meetings, coordinate resources and prepare reports as required, ensuring effective communication of ideas, information, and issues to appropriate stakeholders
  • Provide engineering input 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
  • 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
  • Maintains high awareness of technical trends and developments in the packaging industry
  • Assist in the completion of engineering tasks or projects for higher lever engineers.
  • May be necessary to coordinate the activities of support groups such as purchasing, scheduling, production, etc. Collecting of data from various sections.
  • Performs other job related duties assigned.

Position Requirements :

Knowledge, Skills and Abilities (KSAs)

  • Excellent knowledge of packaging test methodology
  • Excellent understanding of packaging materials' capabilities and equipment
  • Thorough understanding of medical device processes and effect on packaging preferred
  • Able to analyze all aspects of package systems
  • Excellent analytical and problem solving skills.
  • Familiar with of statistical techniques used in developing samples sizes preferred.
  • Experience with 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 physical and structure package testing procedures.
  • Knowledge of GMP / FDA regulations preferred.
  • Ability to create and work from engineering drawings.
  • Excellent communication skills both verbal and written.
  • Background Experiences

  • BS in packaging, mechanical, or related engineering field with 3 yrs relevant work experience in the packaging, medical or regulated industry preferred.
  • Experience in a manufacturing environment for designing, specifying, assembling, and validating packaging / labeling equipment, processes, and software.
  • We provide competitive and comprehensive benefit options that allow you to design your own plan based on your individual needs which include : paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program.

    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.

    We provide competitive and comprehensive benefit options that allow you to design your own plan based on your individual needs which include : paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program.

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