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# Senior Systems Engineer

- **Company:** Abbott Laboratories
- **Location:** Alameda, CA, United States
- **Experience:** Expert
- **Salary:** $114,000.0 - $228,000.0
- **Contract:** Permanent contract
- **Skills:** Systems Engineering, JIRA, Configuration Management, Data Systems, EHealth, Network Interface Controllers, Failure Mode Effects Analysis, Software Product Management, Systems Development Life Cycle, Cloud Services, Requirements Traceability, Software Requirements Analysis, Software Systems, Verification and Validation (Software), Systems Architecture, Jama (Software), Polarion
- **Published:** November 4, 2026
- **Apply:** https://abbott.wd5.myworkdayjobs.com/abbottcareers/job/United-States---California---Alameda/Senior-Systems-Engineer_31166195-1

## About the Role

* 8+ years of experience in systems engineering for regulated environments, ideally in medical devices or software as a medical device.
 * Strong technical breadth across software, IoT systems, with the ability to communicate effectively across disciplines.
 * Hands-on experience with requirements definition/management tools (Jama, ALM, DOORS, Polarion, Ketryx, or similar) and interface control documentation.
 * Hands-on experience with requirements definition/management tools (Jama, Ketryx, or similar) and interface control documentation.
 * Knowledge of core regulatory and quality standards for medical devices (FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601).
 * Familiarity with risk management best practices for medical devices and maintaining hazard analysis/FMEA documentation.
 * Demonstrated systems thinking skills, understanding how individual components affect safety, performance, and usability of the overall system.
 * Excellent communication, collaboration, and documentation skills.

Preferred Qualifications

 * Experience with Model-Based Systems Engineering (MBSE) tools such as Cameo Systems Modeler or Enterprise Architect.
 * Background in biosensor, digital health, or IoT medical device development.
 * Exposure to design history file creation, regulatory submissions, and audits.
 * Experience integrating cloud-based services with medical devices in compliance with security/privacy standards (HIPAA, GDPR).

 * Familiarity with design controls for consumer medical or multifunction devices.

 * Experience with Human Factors Engineering (IEC 62366).

 * Experience with project-management and agile tools (e.g., Jira).

## Description

We are seeking a Systems Engineer to lead design and development efforts across our cloud, and mobile platforms within a regulated medical device environment. This role is based in Alameda, CA, and plays a critical role in ensuring product quality, regulatory compliance, and scalable delivery.

What You'll Work On

 * Define and support software system architecture, safety classification, and system design to enable compliant, high-quality product development.
 * Create and maintain interface control documentation to ensure robust integration between hardware, and data systems.
 * Lead risk management activities, identifying hazards, defining mitigations, and ensuring traceability throughout design and development.
 * Partner with QA/RA to maintain compliance with relevant standards, including FDA 21 CFR 820.30, ISO 13485, ISO 14971, IEC 60601, and IEC 62304.
 * Support verification and validation (V&V) processes which includes planning, execution, and documenting system tests to confirm requirements are met.
 * Facilitate design reviews, coordinate multidisciplinary technical decisions, and champion systems thinking in everyday engineering.
 * Maintain documentation for design history files (DHFs) and ensure full requirements traceability across the product lifecycle.
 * Support defect analysis and disposition while ensuring alignment with safety and risk management processes.

 * Support audits, regulatory submissions, SDLC process definition, non-product software validation, configuration management, and change control activities for software systems.