Senior Systems Engineer

Abbott • Alameda, CA

4d • 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. This role is based onsite in Alameda, California, and leads systems design and development across cloud and mobile platforms in a regulated medical-device environment. The engineer helps ensure product quality, regulatory compliance, and scalable delivery.

The role defines and supports software system architecture, safety classification, and system design; manages interfaces and requirements traceability; leads risk management; and supports verification and validation. The engineer works with Quality Assurance and Regulatory Affairs, coordinates multidisciplinary design decisions, maintains design history documentation, supports defect analysis, and contributes to audits, regulatory submissions, software lifecycle processes, configuration management, and change control.

Requirements

• At least 8 years of systems engineering experience in regulated environments, ideally medical devices or software as a medical device.
• 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 practices and maintaining hazard analysis or FMEA documentation.
• Demonstrated systems thinking and understanding of how components affect overall system safety, performance, and usability.
• Excellent communication, collaboration, and documentation skills.

Nice To Haves

• Experience with Model-Based Systems Engineering 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 and IEC 62366.
• Experience with project-management and agile tools such as Jira.

Responsibilities

• Define and support software system architecture, safety classification, and system design.
• Create and maintain interface control documentation to support integration between hardware and data systems.
• Lead risk management activities, including hazard identification, mitigations, and traceability throughout design and development.
• Partner with Quality Assurance and Regulatory Affairs to maintain compliance with applicable regulatory and quality standards.
• Support verification and validation planning, execution, and documentation of system tests.
• Facilitate design reviews, coordinate multidisciplinary technical decisions, and promote systems thinking.
• Maintain design history files 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 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 earning a bachelor’s degree.
• Career development opportunities with an international company.

What This Job Offers

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