Staff Software Systems Engineer

Abbott • Pleasanton, CA

3d • Onsite

About The Position

The Staff Software Systems Engineer works in Abbott’s Heart Failure Division at its Pleasanton, California location. The role supports the design, development, and testing of complex software systems for medical devices and connected health platforms. It captures and translates customer and stakeholder needs into actionable requirements and specifications, aligns development and testing teams, and provides technical leadership to deliver high-quality software that meets customer needs and regulatory standards.

The engineer leads complex digital health programs involving cloud platforms, mobile applications, connected devices, data pipelines, and clinical workflows. The role partners with business, clinical, regulatory, and engineering stakeholders to define product vision and requirements, contributes to risk management, guides design reviews, and supports requirements traceability, validation, and compliance throughout development. It also plans and organizes program work, resolves issues, and fosters collaboration across teams.

The position requires compliance with FDA regulations, other regulatory requirements, and company policies and procedures. It involves continuous sitting and standing for prolonged periods and travel of 10% of the time.

Requirements

• Bachelor’s degree in software engineering, computer science, or a related engineering field.
• At least 8 years of relevant experience with a bachelor’s degree, or at least 6 years of relevant experience with a master’s degree, or equivalent years of education and experience in engineering and sciences.

Nice To Haves

• Ability to integrate information from varied disciplines, including clinical medicine, engineering, marketing, and regulatory affairs.
• Medical device industry experience.
• Working knowledge of cloud-based platforms such as AWS, Azure, or GCP and mobile application ecosystems.
• Familiarity with standards such as IEC 62304 (Software Lifecycle), ISO 14971, or similar.
• Experience with requirements, configuration, and defect management tools such as DOORS or JIRA.
• Experience working in an enterprise or cross-division business unit model.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work both as a team member and an individual contributor in a fast-paced, changing environment.
• Ability to leverage or engage others to accomplish projects.
• Strong verbal and written communication skills, including the ability to communicate effectively at multiple organizational levels.
• Ability to multitask, prioritize, and meet deadlines in a timely manner.
• Strong organizational and follow-up skills and attention to detail.

Responsibilities

• Lead complex digital health programs spanning cloud platforms, mobile apps, connected devices, data pipelines, and clinical workflows.
• Drive standardized engineering methods and processes that strengthen design rigor and cross-functional alignment.
• Translate ambiguous business and clinical inputs into defined development plans and actionable requirements; resolve issues, prioritize cross-functional trade-offs, and ensure validated, high-quality outputs aligned with regulatory expectations.
• Plan and execute department strategy within the role’s responsibilities; gather information, frame problems, develop and execute plans, track progress, and adjust or measure success to improve development efforts and the organization.
• Partner with business, clinical, regulatory, and engineering stakeholders to define product vision and high-level requirements, then decompose them into detailed software and system requirements and functional specifications for development and testing teams.
• Contribute to risk management activities, including hazard analysis, FMEA, and risk assessments, and ensure risk controls are reflected in requirements, architecture and design, and verification and validation plans.
• Drive design reviews and enforce best practices for requirements traceability, validation, and compliance throughout the development lifecycle.
• Serve as a subject matter expert on designated systems, advising on system behavior, implementation trade-offs, customer and clinical needs, and applicable technologies; participate in cross-functional reviews of work output.
• Organize and manage work to deliver programs and lead execution of assigned work.
• Foster collaboration with cross-functional teams and other leaders to complete work and resolve issues.
• Comply with FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
• Maintain positive and cooperative communication and collaboration with employees, customers, contractors, and vendors at all levels.

Benefits

• Employees may qualify for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, an affordable and convenient path to earning a bachelor’s degree.
• Career development opportunities with an international company.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior