"Alerted.org

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 114,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

+ Career development with an international company where you can grow the career you dream of.

+ Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.

+ An excellent retirement savings plan with a high employer contribution

+ Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program, and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) education benefit - an affordable and convenient path to getting a bachelor’s degree.

+ A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.

+ A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Santa Clara, CA location in the Structural Heart division.

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

As the Development Quality Engineer II, you’ll assure new or modified products conform to requirements and establish compliance with the quality system. This position is responsible for maintaining a strong collaborative partnership with cross-functional team members that facilitates organizational success by protecting patient/user safety and meeting business needs. This position will support the new product development of a novel, non-invasive mitral valve replacement technology and lead completion of design control deliverables.

What You’ll Work On

+ Lead on-time completion of Design Control deliverables

+ Create and ensure on-time execution of Quality Plans for internal development, OEM-based, and design change projects

+ Support Design Verification and Validation planning and execution, including study planning, test method and protocol review, active cross-functional root-cause analysis investigation and resolution activities

+ Lead Risk Management activities, including analyzing field data to support new product development, and supporting Failure Mode Effects Analysis

+ Support design test and inspection method development, and lead method validation activities

+ Ensure Device History File (DHF) content completion, integrity, and regulatory & standards compliance; collaboratively identifying, communicating and resolving gaps

+ Support manufacturing process development and qualification for new product development and product changes

+ Support internal and external audit responses and on-time product re-certifications

+ Support and ensure the establishment of objective, measurable, discrete, and verifiable customer and product requirements

+ Support and ensure objective component specification definitions, supplied component sampling plan development, and vendor qualifications

+ Support the development and review of biocompatibility and sterilization validations

+ Supports R&D product builds for bench testing, animal lab, and clinical activities.

+ Complete Document Change Request Reviews in a timely and objective manner

+ Participates in Corrective Action/Preventive Action (CAPA) and Nonconforming Reports (NCR) processes including the investigation of failures or deviations, as required. Develop and lead other team members.

Other Duties:

+ Additional duties may be identified by functional management based on the current project/business objectives.

+ Support all Divisional initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

Required Qualifications

+ Bachelor’s degree within an Engineering field or related science-based discipline

+ 2-4+ years of related work experience

+ Previous Quality engineering experience and demonstrated use of Quality tools/methodologies

+ Solid verbal, written, and interpersonal skills with ability to effectively communicate at multiple levels in the organization

+ Ability to work in a highly matrixed and geographically diverse business environment.

+ Ability to work within a team and as an individual contributor in a fast-paced, changing environment.

+ Ability to leverage and/or engage others to accomplish projects.

+ Multitasks, prioritizes and meets deadlines in timely manner.

+ Strong organizational and follow-up skills, as well as attention to detail.

+ Ability to travel approximately 5%, including internationally.

Preferred Qualifications:

+ Advanced degree in a technical field

+ Medical device experience, specifically with single use intravascular catheters, implant delivery systems, valves and /or implantable devices

+ Prior experience in the development of early stage medical device technologies

+ Experience working in a broader enterprise/cross-division business unit model

+ Prior experience working with any or all of the following: ISO 13485 Medical Devices – Quality Management System21 CFR Part 820 FDA Quality System Regulations ISO 14971 Medical Devices – Application of Risk Management EU MDR MD SAP Good Manufacturing Practices And Good Documentation Practices

**Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:** www.abbottbenefits.com (http://www.abbottbenefits.com/pages/candidate.aspx)

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com , on Facebook at www.facebook.com/Abbott , and on Twitter @AbbottNews.

The base pay for this position is $79,500.00 – $138,700.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email [email protected]