Staff Engineer, Software Quality

at  Abbott Laboratories

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.

WHAT YOU’LL WORK ON

This position works out of our Pleasanton, CA or Burlington, MA location in the Abbott 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 Staff Software Quality Engineer to ensure our medical devices are developed in accordance with Abbott’s design control requirements and state of the art standards. The Staff Software Quality Engineer will serve as a technical representative providing software quality expertise to product development teams. The Staff Software Quality Engineer is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software.

• Complete Software Quality related tasks and activities for development of medical product software (embedded, Cloud Patient Care Networks, and mobile), non-medical software, and non-product software
• Support software verification and validation activities for new products and software changes in accordance with plans. Review and approve of requirements, software test case protocols/reports, software development plans, and other system and software documentation.
• Participate in meetings to evaluate, prioritize, and develop action plans for addressing issues captured in problem resolution systems.
• 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 design quality engineering function for review and approval of project deliverables.
• 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.
• Work as an individual contributor and provide guidance or oversee work of other Quality Engineering team members.
• Support audits and lead quality system improvement activities.
• Comply with U.S. Food and Drug Administration (FDA) regulations, EUMDR, and other regulatory requirements and Abbott policies, processes, and procedures.