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$173,350–$221,187.
Based on 240 similar postings.
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About Abbott
Abbott Laboratories is a global healthcare company that manufactures and markets a broad and diversified line of health care products including diagnostics, medical devices, nutritionals, and branded generic pharmaceuticals. Industry: Healthcare & Medical Devices
Abbott currently has
193 open roles
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Listed pay typically runs
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across 123 roles with salary data.
The Staff Software Systems Engineer joins the Heart Failure Division to support the design, development, and testing of complex software systems for medical devices and connected health platforms. This role involves leading digital health programs across cloud platforms, mobile apps, data pipelines, and clinical workflows. You will translate ambiguous business and clinical inputs into actionable software specifications, drive standardized engineering methods, and manage risk through hazard analysis and FMEA. Key responsibilities include enforcing requirements traceability, ensuring FDA regulatory compliance, and providing technical leadership for high-quality software solutions. Required skills include experience with cloud-based platforms like AWS, Azure, or GCP, mobile application ecosystems, and tools such as DOORS or JIRA. You will navigate complex technical trade-offs to solve problems within the medical device and digital health domain.
Lead complex digital health programs involving cloud platforms, mobile apps, connected devices, and data pipelines.
Translate ambiguous business and clinical inputs into well-defined software requirements and actionable development plans.
Decompose high-level product visions into detailed functional specifications for development and testing teams.
Conduct risk management activities including hazard analysis, FMEA, and translating risk controls into design requirements.
Drive design reviews and enforce best practices for requirements traceability and regulatory compliance.
Serve as a subject matter expert on system behaviors, implementation trade-offs, and clinical applications.
Plan and execute department strategies to track progress and measure success within the scope of responsibility.
Ensure all software solutions comply with FDA regulations and other applicable industry standards.
What we're looking for
Bachelor's degree in software engineering, computer science, or a related engineering field.
8+ years of relevant experience with a BS degree, or 6 years of relevant experience with an MS degree, or equivalent education and experience.
Demonstrated ability to effectively integrate information from varied disciplines including Clinical Medicine, Engineering, Marketing and Regulatory Affairs (preferred).
Medical device industry experience (preferred).
Working knowledge of cloud-based platforms (AWS, Azure, GCP) and mobile application ecosystems (preferred).
Familiarity with relevant standards such as IEC 62304 (Software Lifecycle), ISO 14971, or similar (preferred).
Experience working with requirements, configuration, and defect management tools like DOORS or JIRA (preferred).
Experience working in a broader enterprise/cross-division business unit model (preferred).
Systems Engineering
Model-Based Systems Engineering
requirements-management
Embedded Firmware
Signal Processing
Data Analysis
Electrical Hardware
Mixed-Signal Hardware
Sensors
ISO 14971
IEC 60601
ISO 14708
Risk Management
Design Controls
Systems Engineering
System Integration
System Architecture
Python
MATLAB
Embedded Software
Firmware
Hardware-Abstraction Layer
Data Mining
Data Analysis
Medical Devices
Product Development