Senior Systems Engineer, Medical IoT (Alameda)

Abbott; Alameda (CA); Presencial; USD 114.000 - 228.000; Jornada completa

Descripción de la vacante

Abbott in Alameda, CA is seeking a Senior Systems Engineer to lead design and development across cloud and mobile platforms within a regulated medical device environment. This onsite role emphasizes product quality, regulatory compliance, and scalable delivery for Lingo biosensing technology.

You will define system architecture, drive risk management, and ensure traceability from DHFs through final verification, collaborating with QA/RA and cross-functional teams.

Formación

• 8+ years of systems engineering in regulated environments (medical devices preferred).
• Broad technical knowledge across software and IoT systems.
• Hands-on experience with requirements tools (Jama, ALM, DOORS, Polarion, Ketryx).
• Knowledge of core regulatory and quality standards (FDA 21 CFR 820, ISO 13485, ISO 14971, IEC 62304, IEC 60601).
• Experience with risk management and performing FMEA/documentation.
• Strong systems thinking and design traceability across lifecycles.
• Excellent communication and documentation skills.

Responsabilidades

• Define and support software system architecture and safety classification.
• Create and maintain interface control documentation for robust hardware/data integration.
• Lead risk management activities with hazard analysis and mitigations.
• Partner with QA/RA to maintain regulatory compliance.
• Support verification and validation planning, execution, and documentation.
• Facilitate design reviews and cross-disciplinary technical decisions.
• Maintain design history files and traceability across the lifecycle.
• Support audits, regulatory submissions, and change control for software systems.

Conocimientos

Systems engineering

Regulated environments

IoT systems

Cross-disciplinary communication

Hazard analysis

Herramientas

Jama

ALM

DOORS

Polarion

Ketryx

Interface control docs

Descripción del empleo

Abbott in Alameda, CA is seeking a Senior Systems Engineer to lead design and development across cloud and mobile platforms within a regulated medical device environment. This onsite role emphasizes product quality, regulatory compliance, and scalable delivery for Lingo biosensing technology.

You will define system architecture, drive risk management, and ensure traceability from DHFs through final verification, collaborating with QA/RA and cross-functional teams.