Staff Software Systems Engineer

abbott; Pleasanton (CA); On-site; USD 100,000 - 200,000; Full time

Benefits offered by this job

Health coverage

Retirement plan

Education benefits

Job summary

Abbott is seeking a Senior Software Systems Engineer in Pleasanton, CA to design, develop and test complex software for medical devices and connected health platforms. You will translate user needs into actionable requirements and provide technical leadership across teams while ensuring regulatory compliance.

Responsibilities include driving product development plans, collaborating with business, clinical and regulatory partners, and delivering high‑quality software solutions within FDA and IEC

Qualifications

• BS in software engineering, computer science or related field.
• Experience levels: 8+ yrs with BS or 6+ yrs with MS.
• Medical device industry experience advantageous.

Responsibilities

• Lead design, development and testing of complex software for medical devices.
• Translate customer and stakeholder requirements into clear specifications.
• Ensure regulatory standards and quality goals are met throughout development.

Skills

Technical leadership

Requirements analysis

Regulatory awareness

Cross-functional collaboration

Education

BS degree in software engineering or related field

MS degree preferred

Tools

DOORS

JIRA

Job description

JOB DESCRIPTION:

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.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

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. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

The base pay for this position is

$100,000.00 – $200,000.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Product Development

DIVISION:

HF Heart Failure

LOCATION:

United States > Pleasanton : 5000 Franklin Dr

WORK SHIFT:

Standard

TRAVEL:

Yes, 10 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf