Staff Software Systems Engineer

Biopharma Asia; Pleasanton (CA); On-site; USD 114,000 - 228,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Tuition reimbursement

Education benefit

Job summary

Abbott in Pleasanton, CA, seeks a Senior Software Systems Engineer to design, develop, and test complex software for medical devices and connected health platforms, translating customer and stakeholder needs into actionable specifications.

You will lead cross-functional teams, drive requirements traceability, risk management, and verification plans, and ensure regulatory compliance across the development lifecycle.

Qualifications

• Bachelor's degree in software engineering, computer science, or a related engineering field.
• 8+ yrs relevant experience and a BS degree, or 6 yrs relevant experience and a MS degree, or equivalent years of education and experience in Engineering and Sciences.

Responsibilities

• Leads complex digital health programs spanning cloud platforms, mobile apps, connected devices, data pipelines, and clinical workflows.
• Drives standardized engineering methods and processes that improve design rigor and cross-functional team alignment.
• Leads structured execution of digital product development, translating ambiguous business and clinical inputs into well-defined plans and actionable requirements.
• Plans and executes department strategy to deliver responsibilities, frames problems, and tracks progress within scope.
• Partners with internal stakeholders to define product vision and high-level requirements, then decomposes them into detailed software requirements.
• Contributes to risk management activities, conducts hazard analysis, and ensures risk controls are translated into requirements and tests.
• Drive design reviews and enforce best practices for requirements traceability, validation, and compliance throughout the lifecycle.
• Organizes and manages work to deliver programs and leads execution; collaborates across teams to resolve issues.

Skills

Software engineering

Regulatory compliance

Requirements management

Cloud platforms (AWS/Azure/GCP)

Medical device knowledge

Education

Bachelor's degree in software engineering, computer science, or a related engineering field

Tools

DOORS

JIRA

Job description

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 122,000 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 your 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.

Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.

An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Pleasanton, CA location in the Heart Failure Division. 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. The Senior Software Systems Engineer is responsible for supporting the design, development, and testing of complex software systems for medical devices and connected health platforms. This role focuses on capturing and translating customer and stakeholder requirements into clear, actionable specifications, ensuring alignment across development and testing teams. Acting as a subject matter expert, this role provides technical leadership and guidance to deliver high-quality software solutions that meet regulatory standards and customer needs.

What You’ll Work On

• Leads complex digital health programs spanning cloud platforms, mobile apps, connected devices, data pipelines, and clinical workflows
• Drives standardized engineering methods and processes that improve design rigor and cross-functional team alignment
• Leads structured execution of digital product development, translating ambiguous business and clinical inputs into well-defined plans and actionable requirements; drives issue resolution, prioritizes cross-functional trade-offs, and ensures validated, high-quality outputs aligned with regulatory expectations.
• Plans and executes the department strategy to deliver upon responsibilities; gathers information, frames problems, devises/executes plans, tracks progress and adjusts/measures success within scope of responsibility to improve development efforts as well as the organization.
• Partners with internal stakeholders (business, clinical, regulatory, and engineering) to define product vision and high-level requirements, then decomposes them into detailed software/system requirements and functional specifications for development and testing teams.
• Contributes to risk management activities including hazard analysis, FMEA, and risk assessments; ensure risk controls are systematically translated into requirements, architecture/design, and verification/validation plans.
• Drive design reviews and enforce best practices for requirements traceability, validation, and compliance throughout the development lifecycle.
• Develops and applies an expert understanding of designated systems as well as serves as a subject matter expert for the development team regarding behaviors, implementation trade-offs, customer needs, satisfaction of customer needs, clinical applications, and the applicable technologies required to solve problems and deliver upon business objectives. Participates in broad cross-functional reviews of work output.
• Organizes and manages work to deliver programs, leads in the execution of assigned work.
• Fosters collaboration with cross-functional teams and other leaders to drive work to completion and resolve issues.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Required Qualifications

• Bachelor's degree in software engineering, computer science, or a related engineering field.
• 8+ yrs relevant experience and a BS degree, or 6 yrs relevant experience and a MS degree, or equivalent years of education and experience in Engineering and Sciences.

Preferred Qualifications

• Demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs.
• Medical device industry experience.
• Working knowledge of cloud-based platforms (AWS, Azure, GCP) and mobile application ecosystems
• Familiarity with relevant standards such as IEC 62304 (Software Lifecycle), ISO 14971, or similar
• Experience working with requirements, configuration, and defect management tools (e.g., DOORS, JIRA, etc.)
• Experience working in a broader enterprise/cross-division business unit model.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.

The base pay for this position is $114,000.00 – $228,000.00. In specific locations, the pay range may vary from the range posted.