Principal Human Factors Engineer

Abbott•Milpitas, CA

4d•$130,700 - $261,300

About The Position

We are seeking a Principal-level Human Factors Engineer to lead the strategic integration of human-centered design across a portfolio of physician-facing medical technologies and patient-facing regulated consumer health solutions. This role is ideal for a seasoned expert who thrives at the intersection of clinical safety, usability, behavioral science, and advanced health technology. You will shape experiences that enable physicians to make efficient, safe, and confident clinical decisions and empower patients to make informed, proactive health decisions through intuitive consumer-grade health technology. As a principal individual contributor, you will operate as a technical authority and strategic partner across product, engineering, clinical, regulatory, and executive teams—driving human factors excellence from concept through commercialization and post-market optimization.

Requirements

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 quickly assimilate advanced domain knowledge and effectively influence program teams on HF strategy, HF deliverables for program scope, research strategy across the product development lifecycle and successful deliverable completion within project timelines, inclusive of FDA or global regulatory submissions.
Proven experience interfacing with healthcare professionals and patients in a highly professional manner.
Proven ability to apply 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.
Demonstrated ability to influence product direction and executive decision-making as a principal individual contributor, inclusive of excellent verbal and written communication and presentation skills.
Strong research design, facilitation, and synthesis skills across qualitative and quantitative methods.
Exceptional communication skills with ability to translate complex findings into clear design and business implications.
Team player: navigates complexity of advocating for user needs while building relationships with program teams.

Nice To Haves

Experience designing for both clinical (HCP) and direct-to-consumer health technologies.
Background in decision-support systems, AI-enabled health tools, or connected health devices.
Familiarity with software as a medical device (SaMD), digital therapeutics, or wearable technologies.
Experience working with global regulatory environments (EU MDR, Health Canada, etc.).
Advanced degree (PhD or MS) in Human Factors or related discipline.

Responsibilities

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 on usability engineering, risk-informed design, and human-centered innovation.
Influence product strategy by translating user needs, clinical workflows, and behavioral insights into design and system requirements.
Partner with executive leadership to ensure human factors considerations shape product roadmap, risk posture, and market differentiation.
Lead and innovate through the ambiguity and tension of user & market needs, technical viability and business timeliness
Lead human factors activities in compliance with: FDA Human Factors Guidance (2016) IEC 62366-1 / IEC 62366-2 ISO 14971 Risk Management AAMI HE75 and related standards TIR 50
Define and execute usability engineering plans (UEPs) and human factors validation strategies.
Conduct use-related risk analyses and integrate findings into design controls and risk management files.
Author and review regulatory documentation including usability validation reports and submissions (510(k), De Novo, PMA as applicable).
Design and conduct exploratory, formative and summative usability studies with: Physicians and clinical staff Patients and caregivers Consumer health users across varying health literacy levels and geographies
Apply mixed-method research approaches including contextual inquiry, simulation-based testing, and behavioral analysis.
Translate research findings into actionable design and system recommendations that improve safety, efficiency, and user confidence.
Determine post-market monitoring methods to demonstrate fulfillment of UX goals
Model and optimize end-to-end workflows across clinical and home environments.
Identify cognitive load, decision friction, and safety risks in complex care pathways.
Partner with design and engineering teams to create intuitive interfaces and interaction models that support rapid, accurate decision-making.
Ensure alignment between clinical-grade reliability and consumer-grade usability.
Collaborate closely with Product Management, Clinical Affairs, Regulatory, Quality, Engineering, Design and other Human Factors team members.
Guide teams on best practices in human-centered design and usability risk mitigation.
Mentor designers, researchers, and engineers in human factors methods and regulatory expectations.
Act as a key liaison with external partners including regulatory bodies, research vendors, and clinical advisors.
Introduce advanced methods (AI-assisted research, simulation environments, real-world evidence analysis) to elevate human factors practice.
Monitor post-market data and real-world use to identify opportunities for continuous usability and safety improvements.
Contribute to thought leadership through publications, conference presentations, or standards participation.