Abbott R&D Product Engineer IV in Alameda, California
Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.
Exciting opportunity to join Abbott's fastest growing division, Diabetes Care, as a member of our device development R&D group. Home of the FreeStyle Libre, the world's #1 continuous glucose monitor, our aim is to improve the lives of the millions living with diabetes.
Responsible for the transfer of new medical product designs to manufacturing in accordance with applicable US and International medical industry regulations and standards. Works with the design team during product development to specify production test methodologies and requirements. Works with the manufacturing team to develop required test equipment and validate the manufacturing process. Also responsible for actively monitoring new product performance and yields.
1.Develop manufacturing test specifications for both PCBA level and High Level Assembly. 2.Conduct and participate in design specification reviews. 3.Manually verify test processes prior to implementation using common electrical test equipment. 4.Create validation protocols (IQ, OQ, PQ) for manufacturing test equipment. Work with Contract Manufacturers to complete. 5.Familiarity with statistical methods for measuring test equipment variation and product capability. 6.Coordinating pilot builds, acceptance, and transition to production activities with overseas Contract Manufacturers. 7.Act as the manufacturing liaison to the product development team. 8.Act as lead to resolve manufacturability issues for new and existing products. 9.Assist the Product Evaluation team with EMC compliance testing for new product development. 10.Communicate effectively and interact with a crossfunctional team, including Mechanical, Electrical, Software, Product Evaluation, OMMIE, Regulatory, Operations, and Quality groups. 11.Identify alternate sources for obsolete parts. 12.Familiarity with Agile document management system and creating Engineering Changes and BOM updates as needed.
BS degree in an engineering or technical discipline or minimum 10 years relevant experience
Strong knowledge of analog/digital PCBA test, fabrication, assembly, and quality engineering for medical device products. Crossfunctional team leader and drive all Operations issues in the development and release of new products. Requires excellent writing and speaking communication skills. Familiarity with C/Labview/Scripting a big plus. Collaborate with multiple internal departments. Developing testing techniques for analog/digital PCBAs. Knowledge of regulatory standards for medical devices (IEC, ISO, FDA). Possess the ability to manage multiple projects. Able to operate effectively under tight schedules.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
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