Senior Design Quality Engineer

3 weeks ago

Atlanta, United States Abbott Laboratories Full time

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.

Job Title

Senior Design Quality Engineer

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. Youâll 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 bachelorâs 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.

The Opportunity

This position works out of our Atlanta, GA location in the Heart Failure Division. In Abbottâs Heart Failure (HF) business, weâre developing solutions to diagnose, monitor and manage heart failure, allowing people to restore their health and get on with their lives.

What Youâll Work On

We are seeking an experienced Sr. Design Quality Engineer to ensure our medical devices are developed in accordance with Abbottâs design control requirements and state-of-the-art product standards. 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.

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.

This and is an ONSITE position.

What Youâll Do

  • Lead and/or support on-time completion of Design Control deliverables for both new product development projects and design change projects.
  • Support the establishment of objective, measurable, discrete, and verifiable customer and product requirements.
  • Support design verification and validation planning & execution, including any cross-functional investigation and resolution activities.
  • Ensure DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps.
  • Lead risk management activities from product concept through commercialization.
  • Support test method development and lead test method validation activities.
  • 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, EU MDR, and other requirements, as applicable.

Education and Experience Youâll Bring

Required

  • Bachelorâs degree in Engineering or Technical Field.
  • Minimum of 5 years of experience in medical device Quality Engineering, Research & Development, or Process / Manufacturing Engineering 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.
  • Experience with software verification and validation activities, including test case protocols and reports and software development plans.

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.abbottbenefits.com



The base pay for this position is $72,700.00 â $145,300.00. In specific locations, the pay range may vary from the range posted.

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