Senior Systems Engineer — Medical Device & IoT

Abbott; Alameda (CA); On-site; USD 114,000 - 228,000; Full time

Benefits offered by this job

Health coverage perks

Retirement plan with employer match

Tuition reimbursement

Job summary

Abbott is seeking a Senior Systems Engineer to lead design and development across our cloud and mobile platforms for Lingo in Alameda, CA. You will ensure product quality and regulatory compliance in a regulated medical device environment.

The role demands a strong systems mindset, hands-on experience with requirements management tools, and collaboration across QA/RA, software, and hardware teams. Join a company recognized for innovation in healthcare and employee development.

Qualifications

• Experience delivering systems engineering in medical devices or regulated software environments.
• Familiarity with requirements management and interface control documentation.
• Strong communication and documentation skills.

Responsibilities

• Define and support software system architecture, safety classification, and design to enable compliant, high-quality product development.
• Create and maintain interface control documents for robust hardware/data system integration.
• Lead risk management activities with hazard analysis and traceability across design and development.
• Collaborate with QA/RA to ensure compliance with FDA 21 CFR 820.30, ISO 13485, ISO 14971, IEC 60601, IEC 62304.
• Support V&V planning, execution, and documentation of system tests to verify requirements.
• Facilitate design reviews and multidisciplinary technical decisions, promoting systems thinking.
• Maintain DHFs and ensure full requirements traceability across lifecycle.
• Support audits, regulatory submissions, SDLC, and software validation activities.

Skills

Systems engineering

Regulated environments

Cross-disciplinary communication

Risk management

Systems thinking

Tools

Jama

ALM

DOORS

Polarion

Ketryx

MBSE tools

Job description

Abbott is seeking a Senior Systems Engineer to lead design and development across our cloud and mobile platforms for Lingo in Alameda, CA. You will ensure product quality and regulatory compliance in a regulated medical device environment.

The role demands a strong systems mindset, hands-on experience with requirements management tools, and collaboration across QA/RA, software, and hardware teams. Join a company recognized for innovation in healthcare and employee development.