Staff Engineer, Software Quality

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, 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 student debt program and 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 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 to ensure our medical devices are developed in accordance with Abbott’s design control requirements and state of the art standards.

The Staff will serve as a technical representative providing software quality expertise to product development teams. The is responsible for executing and maintaining software quality engineering methodologies and providing quality engineering support for software.

WHAT YOU’LL DO

• 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.

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

• Bachelor’s degree, or equivalent experience, in a scientific, technical, or engineering discipline.
• Minimum 8 years of Software Development and Quality Engineering experience or an equivalent combination of education and experience.
• Knowledge of FDA regulations and guidance, ISO 13485, ISO 14971, Software Standards (e.g., 62304), EU Medical Device Regulations and MDSAP

Preferred

• Experience using requirements management tools (e.g., DOORS) and using problem reporting systems (e.g., JIRA).
• Hands-on experience with FMEA / risk management.
• Prior experience in a software-focused company or company with software as a medical device (SAMD)
• Experience developing or maintaining design controls for software development.

The base pay for this position is $95,000.00 $190,000.00. In specific locations, the pay range may vary from the range posted.