Abbott Process Engineer V (OPS/EN/PROF2/13022/055) in Alameda, California
At Abbott, we're committed to helping you live your 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, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
Abbott Diabetes Care are looking for a Staff/Principal level Process Engineer to contribute to resolving significant technical issues and to the development of company objectives. Works independently (or in a lead role) on the design and development significant products/processes, manufacturing equipment. Works independently on identifying new technologies for implementation into new product/process development Exercises independent judgment in identifying, recommending and implementing significant and/or complex new equipment/process improvements to meet new product/process development and regulatory requirements. May lead technical teams in the accomplishment of process engineering activities. Develops networks involving cross functional/cross departmental groups as well as communication to Sr. Management.
Specify, design, verify and validate new manufacturing processes, in accordance with applicable medical regulatory standards.
Responsible for the development of technical project plans and schedules covering all engineering activities (Meeting all Design control and process/product development SOP requirements).
Works in the development of significant process/product specifications, pFMEAs, DOEs, validation protocols.
Works in the creation of schedules and budgets.
Communicate effectively and participate on cross functional development teams.
Participate in technical design reviews for process equipment and product design and requirements documents.
Write and submit Engineering Change Orders, as require.
Act as independent reviewer on programs in which not directly involved.
Responsible for utilizing and maintaining the effectiveness of the quality system.
Ensures that processes and equipment meet all applicable standards.
Development and execution of new processes, equipment, materials, verification and validation Implement approved Design Control procedures for process development in accordance with FDA guidelines.
May be asked to directly manage staff as necessary.
BS in an Engineering/Technical Discipline (Mechanical, Chemical, Electrical or Physics preferred), or equivalent technical or relevant experience. MS degree or PhD ideal. 8 yrs relevant experience. Some experience in technical leadership desirable. SolidWorks and Statistical Analysis experience preferred. Good knowledge of general Engineering principals Solid knowledge of regulations for medical device development, (ISO134851, ISO13485, FDA). Strong technical experience in an engineering discipline (preferably mechanical, chemical or electrical engineering) with excellent written and verbal communication skills are essential. Extensive understanding of processes and materials used in the development and manufacturing of medical devices, particularly diabetes strips. Experience in all of the following:
o Performing complex engineering calculations and relating results to controlled tests, including statistical analysis, tolerance analysis
o Working in a development environment with an emphasis on manufacturing equipment/process/product development
o Writing process/product requirements and design specifications
o Equipment/facility/process commissioning and validation desired
o Working on a development team with an emphasis on minimizing time to market
o Design for manufacture of low cost, high volume electronic products. Solid understanding of GxP, ISO and medical device regulations, particularly with respect to the development of new products/processes in the regulated environment. Experience working in cross functional team environments is desired
ADC Diabetes Care
United States > Alameda : 1360-1380 South Loop Road
Yes, 20 % of the Time
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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