Abbott Senior Mechanical Engineer in Irving, Texas
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
Determines the mechanical makeup of the next generation blood analyzers of the ADD organization. Works with the system engineering group to determine makeup of the system based on user needs and then looks at developing technology and industry trends to meet those needs through mechanical design, as well as the possibility of re-use of existing technology. The engineers in the group are responsible for the mechanisms, fluidic circuits, and structure design that allow us to deliver the next generation concepts to the customers.
Resolve complex technical issues and determine design direction in new technology areas. Works on the design and development of medical devices. Exercises judgment in identifying, recommending and implementing designs to meet development and regulatory requirements. Works on identifying new technologies for implementation into new product development and/or the identification of process improvement opportunities May lead technical teams in the accomplishment of mechanical engineering activities. Develops networks involving cross functional groups
Specify, design, verify, and validate new product designs, in accordance with applicable medical regulatory standards.
Responsible for the development of technical project plans and schedules covering all engineering activities.
Works on the development of product specifications, FMEAs, DOEs, verification and validation protocols.
Works in the creation of schedules.
Participate in technical design reviews of new product designs and requirements. documents.
Write and submit Engineering Changes, as required.
Responsible for utilizing and maintaining the effectiveness of the quality system.
Responsible for compliance with applicable Corporate and Divisional Policies.
Bachelors degree in Mechanical Engineering or equivalent engineering or scientific discipline. Masters degree ideal. 6 yrs relevant experience and a BS degree or 4 yrs relevant experience and a MS degree. Good knowledge of general engineering principles Knowledge of regulations for medical device development, (ISO15197, ISO13485, FDA). Strong technical experience in mechanical engineering with excellent written and verbal communication skills is essential. Solid understanding of processes and materials used in the development and manufacturing of medical devices. Solid experience in performing complex engineering calculations and relating results to controlled tests, including statistical analyses and tolerance analyses. Experience in all of the following: oWorking in a development environment with an emphasis on new medical device development. oWriting product requirements and design specifications. oSupport equipment/facility/process commissioning and validation desired oDesign for manufacture of low cost, high volume disposable products. Familiarity with GxP, ISO, and medical device regulations.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
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