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.
At 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 Senior Sustaining Mechanical Engineer This position on our new sustaining R&D engineering team will be a key Mechanical Engineer who will both support on market medical product designs as well as new product support including for Abbott Diabetes Care’s FreeStyle Libre product.
The Senior Sustaining Mechanical Engineer will contribute to resolving significant technical issues for medical products.
This position will work independently or in a lead role on the investigation and improvement of products with key cross functional teams to perform failure analysis, identify design improvements, create the design updates, test to requirements, and document and release to manufacturing.
WHAT YOU’LL DO Lead investigations with a focus on design and manufacturing process improvements to reduce complaints Serve as 3rd tier support for complaint investigations, including mentoring of junior engineers.
Responsible for the development of technical project plans and schedules covering engineering activities, meeting all design control and product development SOP requirements.
Works in the development of significant design specifications, FMEAs, DOEs, verification and validation protocols.
Specify, design, verify and validate Mechanical designs, in accordance with applicable medical regulatory standards.
Participates in technical design reviews of products and design requirements documents Writing, submittal, and approval of Engineering Changes, as required.
May review and approve ECs.
Act as independent reviewer on programs in which not directly involved.
Responsible for utilizing and maintaining the effectiveness of the quality system.
Ensures that products meet all applicable standards.
Communicates effectively and participates on cross functional teams.
EDUCATION AND EXPERIENCE YOU’LL BRING BS degree with 8 years relevant experience or a MS degree 6 years relevant experience.
Some experience in engineering management or technical leadership desirable.
Good knowledge of general engineering principles.
Solid knowledge of regulations for medical device development.
Design for manufacture of low cost, high volume products containing injection molded parts, with solid understanding of GxP, ISO and medical device regulations, particularly with respect to the development of new products in a regulated environment.
Strong technical experience in mechanical engineering discipline with extensive understanding of processes and materials used in the development and manufacturing of medical devices (ISO15197, ISO134851, ISO13485, FDA).
Performing complex engineering calculations and relating results to controlled tests, including statistical analysis, tolerance analysis.
Working in a development environment with an emphasis on failure analysis and complaint investigation process improvement.
Writing product requirements and design specifications.
Support equipment/facility/process commissioning and validation desired.
Experience working in cross-functional team environments is required.
Excellent written and verbal communication skills is essential.
WHAT 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 assistance Financial security through competitive compensation, incentives and retirement plans Health care and well-being programs including medical, dental, vision, wellness and occupational health programs Paid time off 401(k) retirement savings with a generous company match The stability of a company with a record of strong financial performance and history of being actively involved in local communities Learn more about our benefits that add real value to your life to help you live fully: http://www.abbottbenefits.com/pages/candidate.aspx Follow 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.
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