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

Working at Abbott

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

1. Career development with an international company where you can grow the career you dream of.
2. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO.
3. An excellent retirement savings plan with high employer contribution.
4. Tuition reimbursement, the student debt program, and education benefit – an affordable and convenient path to getting a bachelor’s degree.
5. 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.
6. A company that is recognized as one of the best big companies to work for as well as a best place to work for working mothers, executives, and scientists.

The Opportunity

Leading an active lifestyle is important to the many people we serve. 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. Design Quality Engineer to ensure our medical devices are developed in accordance with Abbott’s design control requirements and state-of-the-art product standards.

This position works out of our Atlanta, GA or Pleasanton, CA location in the Heart Failure division and is an ONSITE position.

What You’ll Work On

The Sr. Design Quality Engineer will serve as a technical representative providing design quality expertise to product development teams and is responsible for maintaining a strong collaborative partnership with cross-functional team members to achieve patient/user safety, customer satisfaction, and organizational success.

What You’ll Do

1. Lead and/or support on-time completion of Design Control deliverables for both new product development projects and design change projects.
2. Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements.
3. Support design verification and validation planning & execution, including any cross-functional investigation and resolution activities.
4. Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps.
5. Lead risk management activities from product concept through commercialization.
6. Support test method development and lead test method validation activities.
7. Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications.
8. Support biocompatibility and sterilization qualifications.
9. Support audits and quality system improvement activities.
10. Comply with Abbott, U.S. FDA, EU MDR, and other requirements, as applicable.

Education and Experience You’ll Bring

Required

1. Bachelor’s degree in Engineering or Technical Field.
2. Minimum of 5 years of experience in medical device Quality Engineering, Research & Development, or Process/Manufacturing Engineering with experience supporting product development.
3. Experience in test method development and validation.
4. Experience in preparing risk assessments, FMEA, and other risk documents.

Preferred

1. Advanced degree in Biomedical Engineering or related discipline.
2. Experience in active implantable medical devices.
3. Experience in electro-mechanical medical devices and associated regulations/standards.
4. Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA).
5. Working knowledge of statistics and its application to verification and validation.
6. Experience with software verification and validation activities, including test case protocols and reports and software development plans.

The base pay for this position is $72,700.00 – $(phone number removed). In specific locations, the pay range may vary from the range posted.