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 115,000 colleagues serve people in more than 160 countries.
JOB DESCRIPTION:
Working at Abbott
At Abbott, you can do work that matters, grow, and learn, care for yourself and 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.
- Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
- An excellent retirement savings plan with high employer contribution
- Tuition reimbursement, the Freedom 2 Save student debt program and FreeU 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.
What You’ll Work On
This position works out of our Pleasanton, CA location in the Heart Failure Division. This is an ONSITE position.
In Abbott’s Heart Failure (HF) business, we’re developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.
We are seeking an experienced Sr. Development Quality Engineer to ensure our medical devices are developed in accordance with Abbott’s design control requirements and state of the art product standards. The Sr. Development Quality Engineer will serve as a technical representative providing development quality expertise to product development teams.
Responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient/user safety, customer satisfaction, and organizational success. Each employee can make a difference at Abbott and has the power, either individually or as a team, to influence the success of the company. We are team-oriented, fast-paced and progressive. We value people with great ideas who partner with others both internally and externally to accomplish goals.
WHAT YOU’LL DO
- Lead and/or support on-time completion of Design Control deliverables.
- Support the establishment of objective, measurable, and verifiable product requirements.
- Support Design Verification and Validation planning & execution, including any cross-functional investigation and resolution activities.
- Lead Risk Management activities from product concept through commercialization.
- Support test method development and lead test method validation activities.
- Support manufacturing process development & qualification for new product and design changes.
- Support the establishment of component specification definitions, supplied component sampling plan development and vendor qualifications.
- Support biocompatibility and sterilization qualifications.
- Support audits and quality system improvement activities.
- Comply with Abbott, U.S. FDA, EUMDR and other requirements, as applicable.
EDUCATION AND EXPERIENCE YOU’LL BRING
Required
- Bachelor’s degree in Engineering or Technical Field.
- Minimum of 5 years of experience in medical device R&D, Process/Manufacturing Engineering, and/or Quality with experience supporting product development.
- Experience in test method development and validation.
- Experience in preparing risk assessments, FMEA and other risk documents.
Preferred
- Advanced Degree in Biomedical Engineering or related discipline.
- Experience in active implantable medical devices.
- Experience in electro-mechanical medical devices and associated regulations/standards.
- Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA).
- Working knowledge of statistics and its application to verification and validation.
The base pay for this position is
$82,100.00 – $164,100.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
HF Heart Failure
LOCATION:
United States > Pleasanton : 6101 Stoneridge Dr
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
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
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