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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.
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.
Required Qualifications
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.
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
Knowledge of core regulatory and quality standards for medical devices (FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601).
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).
Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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The base pay for this position is $114,000.00 – $228,000.00. In specific locations, the pay range may vary from the range posted.
