- Maintain and follow TMC Quality System requirements; including but not limited to understanding of change control, validation, documentation practices, and design control requirements.
- Collaborate, maintain cross-functional partnerships and coordinate activities as necessary with groups that include but are not limited to supplier quality, purchasing, manufacturing engineering, quality compliance, regulatory, and system engineering.
- Manage and lead multiple projects simultaneously.
- Evaluate and communicate business (timing, cost) impact of design changes.
- Lead and execute product design change projects from evaluation through validation.
- Develop project schedules, attend meetings, coordinate resources and prepare reports as required, ensuring effective communication of ideas, information, and issues to appropriate stakeholders
- Provide technical assistance and leadership in the planning and implementation of complex design change projects to develop and qualify new materials, molds, etc.
- Assist in the completion of engineering tasks or projects lead by more experienced engineers.
- Performs other job related duties assigned.
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Engineer II - Elkton, United States - Terumo
Description
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 product design change projects in support of existing operations.
Job Details/Responsibilities
o Excellent knowledge of material and product test methodology
o Excellent understanding of material capabilities and manufacturing processes
o Thorough understanding of medical device processes and effect on product performance preferred
o Excellent analytical and problem-solving skills.
o Thorough knowledge of statistical techniques, DMAIC/six-sigma certification preferred.
o Knowledge of equipment and process validations, including development of protocols and execution of protocols.
o Successful experience leading project teams is preferred.
o Thorough knowledge of equipment and tools in laboratory testing and inspection systems.
o Knowledge of GMP/FDA regulations preferred.
o Ability to create and work from engineering drawings.
o Excellent communication skills both verbal and written.
Qualifications/ Background Experiences
BS in mechanical or related engineering field with at least 3 yrs relevant work experience in the medical or regulated industry preferred
Experience in a manufacturing environment for designing, specifying, assembling, and validating raw material, sub-components, and finished good product.
Experience in catheter manufacturing processes and/or catheter prototyping required.
Additional experience in manufacturing processes for other types of medical devices a plus.
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.
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