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 Quality Engineer, Software
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
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 or Burlington, MA or Atlanta, GA 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 Senior Software 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 Senior Software Quality Engineer will serve as a technical representative providing software quality expertise to product development teams. The Senior Software Quality Engineer is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software. Ensures software systems are developed, validated and maintained in compliance with regulatory and business procedures.
WHAT YOU’LL DO
- Complete SW Quality related tasks and activities in accordance with Quality System Requirements.
- Support software verification and validation activities for new products and software changes in accordance with plans. This includes, but is not limited to, review and approval of software test case protocols and reports, review of software development plans, and review of other system and software documentation.
- Participate in meetings to prioritize, review and/or approve of action plans for addressing issues captured in problem resolution systems during development.
- Perform risk evaluation and associated management activities related to software development including FMEA, product risk analysis, and mitigation of software issues.
- Participate in technical and management reviews to ensure design plans, product design and deliverables related to product software are met. Represent the quality engineering function for the review and approval of designated design outputs.
- Support non-product software validation by assessing the need for validation and preparing and/or supporting protocols, reports and other documentation as required.
- May be involved with supporting product cybersecurity assessments in conjunction with a cross-functional team.
- Drive best practices for establishing requirements and completing design verification and validation especially as it relates to user needs.
- Work as an individual contributor and may provide guidance or oversee work of other QE team members.
- 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, or equivalent experience, in a scientific, technical, or engineering discipline.
- Minimum 4 years of Software Quality Engineering experience or an equivalent combination of education and experience.
- Ability to work in a highly matrixed and geographically diverse business environment.
Preferred
- Advanced Degree in related discipline.
- Prior medical device experience.
- Knowledge of requirements management tools (e.g., DOORS) and use of problem reporting systems (e.g., JIRA).
- Experience with FMEA/risk management.
- Knowledge of FDA regulations and software guidance, IEC 62304, IEEE 1012, ISO 13485, and ISO14971.
* 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:
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.
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The base pay for this position is $83,600.00 – $167,200.00. In specific locations, the pay range may vary from the range posted.
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