JOB DESCRIPTION:The Opportunity:
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. The location for the on-site position can be Milpitas or Alameda, California.
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.
Key ResponsibilitiesStrategic Human Factors Leadership- 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
Regulatory & Risk-Driven Usability Engineering- Lead human factors activities in compliance with:
- FDA Human Factors Guidance, 2026
- IEC 62366-1 / IEC 62366-2
- ISO 14971 Risk Management
- AAMI HE75 and related standards
- TIR 50
- Define and execute usability engineering plans (UEPs) through 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).
User Research & Insight Generation- 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
Experience & Workflow Optimization- 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.
Cross-Functional Collaboration- 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.
Innovation & Continuous Improvement- 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.
QualificationsRequired- 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.
Preferred- 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.
Success Outcomes (First 12-18 Months)- Establish a scalable human factors framework integrated into product development lifecycle.
- Deliver successful formative and summative usability studies supporting regulatory submissions.
- Demonstrably reduce use-related risk and improve workflow efficiency across core products.
- Elevate organizational maturity in human-centered design and safety-driven innovation.
- Strengthen alignment between clinical performance, user confidence, and product adoption.
Why This Role MattersThis is a high-impact opportunity to shape technologies that directly influence
clinical decision quality, patient safety, and everyday health behaviors. Your work will help ensure that complex medical and consumer health technologies are not only compliant and effective-but deeply intuitive, trusted, and empowering for the people who rely on them.
The base pay for this position is $130,700.00 - $261,300.00
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:Product Development
DIVISION:ADC Diabetes Care
LOCATION:United States > Milpitas : 1820 McCarthy Blvd
ADDITIONAL LOCATIONS:United States > Alameda : 1360-1380 South Loop Road
WORK SHIFT:Standard
TRAVEL:Yes, 20 % 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)
