Systems Engineer (SaMD)

Abbott • Alameda, CA

1d • $114,000 - $228,000

About The Position

At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. ABOUT LINGO Lingo is building a cutting‑edge digital health platform that fuses continuous biosensor data, high‑performance backend engineering, and advanced analytics to help people live healthier, longer, fuller lives. Our technology includes a regulated Software as a Medical Device (SaMD) ecosystem, requiring rigorous safety, quality, and compliance practices across the product lifecycle. THE OPPORTUNITY We are seeking a Systems Engineer to join our team and ensure our biosensor platform is designed, integrated, and verified according to the highest engineering and regulatory standards. This multidisciplinary role bridges software, hardware, and data systems, supporting requirements definition, managing interfaces, shaping architecture and guiding our product from concept through verification, validation, and regulatory submission. You will collaborate closely with engineering, quality, clinical, and product teams to ensure our system meets user needs, integrates safely and effectively, and remains compliant with FDA, HIPAA, ISO 13485, and EU MDR standards. Your work will directly influence product safety, patient outcomes, and regulatory approval timelines.

Requirements

• 5+ years of experience in systems engineering for regulated environments, ideally in medical devices or SaMD.
• 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.

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/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).

Responsibilities

• Define and support SaMD 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 SaMD systems.

Benefits

• 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 a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

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