Lead Product Engineer

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 109,000 colleagues serve people in more than 160 countries.About AbbottAt Abbott, we believe people with diabetes should have the freedom to enjoy active lives. That''s why we''re focused on helping people with diabetes manage their health more effectively and comfortably, with life-changing products that provide accurate data to drive better-informed decisions. We''re revolutionizing the way people monitor their glucose levels with our new sensing technology. Our location in Alameda, CA, currently has an opportunity for a Lead Product Engineer. The engineer will be responsible for the transfer of new medical product designs to manufacturing in accordance with applicable US and International medical industry regulations and standards. They will work with the design team during product development to specify production test methodologies and requirements. They will work with the manufacturing team to develop required test equipment and validate the manufacturing process. The engineer is responsible for product sustaining activities and for functional supervision of the Product Engineering Group.WHAT YOU''LL DOFunction as product engineering group technical lead.Responsible for the development of project plans and schedules covering all engineering activities (Meeting all Design control and product development SOP requirements).Manage cross functional engineering teams developing meter products. Communicate effectively and participate on a cross functional design team.Participate in technical design reviews for hardware, PCBs, Mechanical assemblies, Software and requirements documents.Develop manufacturing test specifications including ICT, functional, and final test.Conduct and participate in design specification reviews.Manually verify test processes prior to implementation using common electrical test equipment. Specify and validate manufacturing test processes for medical monitoring instruments in accordance with applicable regulatory standards.Utilize statistical methods for determining variation and performance of test equipment.Coordinate pilot builds, acceptance, and transition to production activities with overseas Contract Manufacturers.Act as the manufacturing liaison to the product development team. Act as lead to resolve manufacturability issues for new and existing products.Assist the design team in EMC compliance testing for new product municate effectively and interact with a cross functional team, including Mechanical, Electrical, Software, Systems, Regulatory, Operations, and Quality groups.Identify alternate sources for obsolete parts.Responsible for implementing and maintaining the effectiveness of the quality system.Travel nationally/internationally 10-20% of the time.EDUCATION AND EXPERIENCE YOU''LL BRINGRequiredBachelor''s degree in an engineering or technical discipline10 yrs relevant experience in product engineering and at least 5 yrs of device manufacturing experience.Strong knowledge of analog/digital PCBA test, fabrication, assembly, and quality engineering for consumer or medical device products.Cross functional team leader and drive all Operations issues in the development and release of new products.Excellent written and verbal communication skills.Ability to collaborate with multiple internal departments.Experience developing testing techniques for analog/digital PCBAs.Strong knowledge of defined development process that is consistent with ISO, FDA design control standards or requirements.Possess the ability to manage multiple projects and maintain composure under tight schedules.Familiarity with documentation control tools and writing Engineering Change Orders, as requiredStrong knowledge of defined development process that is consistent with ISO, FDA or any recognized quality standards and requirements.PreferredFamiliarity with C/Labview/ScriptingStrong knowledge regulations and standards affecting IVDsExperience in designing medical devices in an FDA regulated environmentWHAT WE OFFER At Abbott, you can have a good job that can grow into a great career. We offer:Training and career development, with onboarding programs for new employees and tuition assistanceFinancial security through competitive compensation, incentives and retirement plansHealth care and well-being programs including medical, dental, vision, wellness and occupational health programsPaid time off401(k) retirement savings with a generous company matchThe stability of a company with a record of strong financial performance and history of being actively involved in local communitiesLearn more about our benefits that add real value to your life to help you live fully: your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

Created: 2021-11-29