Senior Systems Engineer

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

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Systems engineering

Regulated environments

IoT systems

Cross-disciplinary communication

Hazard analysis

Tools

Jama

ALM

DOORS

Polarion

Ketryx

Interface control docs

Job description

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

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 aSystems Engineerto lead design and development efforts across ourcloud, and mobile platformswithin a regulated medical device environment. This role is based inAlameda, 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.
• 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.

Preferred Qualifications

• 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.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal

#software

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.

JOB FAMILY:

Product Development

DIVISION:

LNGO Lingo

LOCATION:

United States > Alameda : 2901 Harbor Bay Parkway

WORK SHIFT:

Standard

TRAVEL:

Yes, 5 % of the Time

MEDICAL SURVEILLANCE:

Not Applicable

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf