Principal Human Factors Engineer

Abbott

. Define and drive the human factors vision and strategy across physician- and patient-facing medical and digital health solutions .

Posted 9/23/2026full-timeMilpitas • California • United StatesLead💰 $130,700 - $261,300 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in usability engineering and human-centered design, with a strong focus on regulatory compliance and risk management in medical device and digital health environments. Proven ability to translate user needs into actionable design requirements while collaborating effectively with cross-functional teams.

Highest-signal resume keywords

Usability EngineeringHuman-Centered DesignRegulatory SubmissionsRisk ManagementUser-Centered Design Principles

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Usability EngineeringHuman Factors ValidationRisk-Informed DesignBehavioral AnalysisClinical Workflow AnalysisUsability StudiesRegulatory ComplianceDesign ControlsMixed-Method ResearchPost-Market Monitoring

Soft Skills

Excellent CommunicationInfluencing SkillsMentoringCollaborationRelationship Building

Tools & Technologies

AI-Assisted ResearchSimulation EnvironmentsExploratory StudiesFormative StudiesSummative Studies

Industry Keywords

FDA Human Factors GuidanceIEC 62366-1ISO 14971AAMI HE75510(k) SubmissionsDe Novo SubmissionsPMA SubmissionsDigital HealthMedical Device DevelopmentHuman-Computer Interaction

About the role

Key responsibilities & impact

Define and drive the human factors vision and strategy across physician- and patient-facing medical and digital health solutions
Serve as a subject matter expert in usability engineering, risk-informed design, and human-centered innovation
Translate user needs, clinical workflows, and behavioral insights into design and system requirements
Partner with executive leadership on product roadmaps, risk posture, and market differentiation
Lead human factors activities in compliance with FDA Human Factors Guidance, IEC 62366-1/IEC 62366-2, ISO 14971, AAMI HE75, and TIR 50
Define and execute usability engineering plans and human factors validation strategies
Conduct use-related risk analyses and integrate findings into design controls and risk management files
Author and review usability validation reports and regulatory submissions, including 510(k), De Novo, and PMA submissions as applicable
Design and conduct exploratory, formative, and summative usability studies with physicians, clinical staff, patients, caregivers, and consumer health users
Apply contextual inquiry, simulation-based testing, behavioral analysis, and other mixed-method research approaches
Translate research findings into design and system recommendations improving safety, efficiency, and user confidence
Determine post-market monitoring methods and monitor post-market data and real-world use
Model and optimize workflows across clinical and home environments
Identify cognitive load, decision friction, and safety risks in complex care pathways
Partner with design and engineering teams on intuitive interfaces and interaction models
Collaborate with Product Management, Clinical Affairs, Regulatory, Quality, Engineering, Design, and Human Factors teams
Guide teams on human-centered design and usability risk mitigation
Mentor designers, researchers, and engineers
Liaise with regulatory bodies, research vendors, and clinical advisors
Introduce AI-assisted research, simulation environments, and real-world evidence analysis
Contribute to thought leadership through publications, conference presentations, or standards participation
Establish a scalable human factors framework within the product development lifecycle
Deliver formative and summative usability studies supporting regulatory submissions
Reduce use-related risk and improve workflow efficiency across core products

Requirements

What you’ll need

Bachelor’s or Master’s degree in Human Factors, Human-Computer Interaction, Biomedical Engineering, Psychology, Industrial Engineering, or related field
8+ years of human factors/usability engineering experience in regulated medical device, digital health, or combination product environments
Proven ability to assimilate advanced domain knowledge and influence program teams on human factors strategy, deliverables, research strategy, and regulatory submissions
Experience interfacing professionally with healthcare professionals and patients
Experience applying user-centered design and human factors engineering principles to product research, development, and design
Experience in medical device development
Deep knowledge of usability engineering standards and risk management integration
Ability to influence product direction and executive decision-making as a principal individual contributor
Excellent verbal, written communication, and presentation skills
Strong research design, facilitation, and synthesis skills across qualitative and quantitative methods
Ability to translate complex findings into clear design and business implications
Ability to navigate complexity while advocating for user needs and building relationships with program teams

Benefits

Comp & perks

Travel opportunity: 20% of the time
Equal Opportunity Employer protections