Staff Software Systems Engineer

Abbott • Pleasanton, CA

4d • $114,000 - $228,000 • Onsite

About The Position

This position is based in Abbott’s Heart Failure Division in Pleasanton, California. The engineer supports the design, development, and testing of complex software systems for medical devices and connected health platforms. The role translates customer and stakeholder needs into actionable requirements and specifications, aligns development and testing teams, and provides subject matter expertise and technical leadership to deliver high-quality solutions that meet customer needs and regulatory standards.

The role leads digital health programs spanning cloud platforms, mobile applications, connected devices, data pipelines, and clinical workflows. It shapes product vision and requirements with business, clinical, regulatory, and engineering partners; manages structured development execution and cross-functional trade-offs; and contributes to risk management, design reviews, traceability, validation, and compliance. The position also plans and tracks work within its area of responsibility, supports departmental strategy, and collaborates across teams to resolve issues and complete programs.

The position requires compliance with FDA and other applicable regulations, company policies, procedures, and work assignments. It includes travel approximately 10% of the time and prolonged sitting and standing. The role is listed under the Product Development job family and Heart Failure division.

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, ISO 14971, or similar.
• Experience with requirements, configuration, and defect management tools such as DOORS or JIRA.
• Experience in a broader enterprise or cross-division business unit model.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work both collaboratively and as 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, with attention to detail.

Responsibilities

• Lead complex digital health programs involving cloud platforms, mobile apps, connected devices, data pipelines, and clinical workflows.
• Drive standardized engineering methods and processes to improve design rigor and cross-functional alignment.
• Translate business and clinical inputs into development plans and actionable requirements; drive issue resolution, prioritize cross-functional trade-offs, and deliver validated outputs aligned with regulatory expectations.
• Plan and execute departmental strategy within the scope of responsibility; gather information, frame problems, devise and execute plans, track progress, and adjust or measure success.
• 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.
• Contribute to risk management activities, including hazard analysis, FMEA, and risk assessments, and ensure risk controls are reflected in requirements, architecture, design, and verification and validation plans.
• Lead design reviews and promote requirements traceability, validation, and compliance throughout the development lifecycle.
• Serve as a subject matter expert on designated systems, including system behavior, implementation trade-offs, customer needs, clinical applications, and relevant technologies.
• Organize and manage work to deliver programs and lead execution of assigned work.
• Collaborate with cross-functional teams and leaders to complete work and resolve issues.
• Comply with FDA regulations, other regulatory requirements, company policies, procedures, processes, and task assignments; maintain cooperative communications with employees, customers, contractors, and vendors.

Benefits

• Career development opportunities with an international company.
• 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, described as an affordable and convenient path to a bachelor’s degree.
• Health and wellness benefits.

What This Job Offers

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