Senior Systems Engineer

Job Description

Meet Lingo, a new biosensing technology that provides users a window into their body. Lingo tracks key biomarkers such as glucose, ketones, and lactate to help people make better decisions about their health and nutrition. Biowearable technology will digitize, decentralize and democratize healthcare, enabling consumers to take control of their own health.

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

THE OPPORTUNITY

This Senior Systems Engineer position works onsite in our Alameda, CA location for Lingo.

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.

• 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.

• 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.

• 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).