Senior Systems Engineer

Abbott • Alameda, CA

6d • $114,000 - $228,000 • Onsite

About The Position

Abbott is seeking a Senior Systems Engineer for its Lingo biosensing technology business. Lingo tracks biomarkers such as glucose, ketones, and lactate to help users make informed decisions about their health and nutrition. The role leads design and development across cloud and mobile platforms in a regulated medical device environment and is based onsite in Alameda, California. It contributes to product quality, regulatory compliance, and scalable delivery.

The engineer defines and supports system architecture, safety classification, and design; coordinates integration and risk management; and partners with Quality Assurance and Regulatory Affairs to meet applicable medical-device standards. The role also supports verification and validation, design reviews, requirements traceability, design history files, defect analysis, audits, regulatory submissions, and software lifecycle and configuration-control activities. The position requires cross-disciplinary collaboration and strong systems thinking.

Requirements

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

Nice To Haves

• 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 and privacy standards such as HIPAA and 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 such as Jira.

Responsibilities

• Define and support software system architecture, safety classification, and system design for compliant, high-quality product development.
• Create and maintain interface control documentation for integration between hardware and data systems.
• Lead risk management activities, including identifying hazards, defining mitigations, and maintaining traceability throughout design and development.
• Partner with QA/RA to maintain compliance with applicable standards, including FDA 21 CFR 820.30, ISO 13485, ISO 14971, IEC 60601, and IEC 62304.
• Support verification and validation by planning, executing, and documenting system tests to confirm requirements are met.
• Facilitate design reviews, coordinate multidisciplinary technical decisions, and promote systems thinking in engineering.
• Maintain design history file documentation and full requirements traceability across the product lifecycle.
• Support defect analysis and disposition in alignment with safety and risk management processes.
• Support audits, regulatory submissions, SDLC process definition, non-product software validation, configuration management, and change control for software systems.

Benefits

• 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 high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, an affordable and convenient path to a bachelor's degree.
• Career development opportunities with an international company.
• Health and wellness benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: No Education Listed