Human Factors Specialist - Medical Devices & Digital Health

  About Myant:

At Myant, our mission is to help people Live Younger, Longer by transforming healthcare from episodic, reactive care to proactive, preventive health management. Through our pioneering connected textiles and continuous monitoring technology, we bridge the gap between individuals, their families, and healthcare providers—creating a world where quality healthcare is more accessible, personalized, and preventative.

Powered by extensive, multidisciplinary R&D, Myant combines expertise in textile science and computing, biometrics, AI, and clinical research to develop technologies that seamlessly integrate into everyday life. Our innovation engine continuously expands the platform’s capabilities, addressing cardiovascular health, stress management, sleep optimization, and more.

With global ambitions, Myant is building a worldwide presence—collaborating with healthcare systems, clinics, researchers, and partners to set a new standard in connected health. Our goal is not just to improve care, but to fundamentally redefine the relationship people have with their health, shifting the focus from sick care to lifelong wellness.

By combining cutting-edge biometric sensing, AI-powered insights, and evidence-based behavioral coaching, Myant helps individuals and healthcare teams work together to prevent disease, optimize wellness, and unlock healthier, longer lives.

Role Overview:

The Human Factors Specialist will support the design, development, and optimization of Myant Health’s medical devices, digital health platforms, and connected care solutions by ensuring products are intuitive, safe, effective, and accessible for patients, caregivers, clinicians, and other end users.

This role serves as the voice of the user throughout the product development lifecycle and works cross-functionally with Product Management, UX/UI Design, Engineering, Clinical Affairs, Regulatory Affairs, Quality Assurance, and Commercial teams to integrate human-centered design principles into software, hardware, wearable technologies, and clinical workflows.

The ideal candidate combines strong analytical and research capabilities with a deep understanding of healthcare environments, human behavior, usability engineering, and regulatory expectations for medical device development.

Key Responsibilities:

Human Factors Engineering & Usability

• Lead and support human factors engineering activities throughout the product development lifecycle in accordance with applicable regulatory standards and usability engineering best practices.
• Develop and maintain usability engineering documentation including:
  • Human Factors Engineering Plans
  • Use Specifications
  • User Profiles
  • Task Analyses
  • Use-Related Risk Analyses
  • Usability Engineering Files
  • Human Factors Engineering Reports
• Conduct contextual inquiry, workflow assessments, ethnographic observations, and user research activities to understand real-world clinical and patient environments.
• Identify use-related hazards and collaborate with cross-functional teams to implement appropriate risk mitigations.
• Translate user needs, workflow insights, and research findings into actionable product requirements, design recommendations, and development priorities.
• Evaluate adoption barriers and usability challenges for medical devices and digital health technologies and recommend improvements to engagement, adherence, safety, and long-term utilization.

User Research & Validation

• Design, execute, and analyze formative usability studies, simulated-use evaluations, pilot studies, and summative validation studies.
• Develop study protocols, moderator guides, data collection instruments, and final study reports.
• Facilitate usability testing sessions with patients, healthcare professionals, caregivers, and other stakeholder groups.
• Analyze qualitative and quantitative usability data and communicate findings clearly to Product, Design, and Engineering teams.
• Identify opportunities to improve usability, accessibility, workflow integration, onboarding experiences, and overall user experience.

Product Development Collaboration

• Partner closely with Product Management, UX/UI Design, and Engineering teams to integrate human-centered design principles into product development activities.
• Support design reviews and provide usability engineering expertise throughout concept development, implementation, verification, and validation phases.
• Evaluate user interfaces, alarms, notifications, controls, displays, instructions for use, onboarding experiences, and training materials.
• Participate in risk management activities and contribute to design verification and validation planning.
• Collaborate with Clinical Affairs, Regulatory Affairs, and Quality teams to ensure alignment between usability, safety, and compliance objectives.

Clinical Workflow & Technology Adoption

• Assess clinical and operational workflows within hospitals, clinics, remote patient monitoring programs, and home-use environments.
• Identify workflow optimization opportunities that improve adoption, operational efficiency, patient engagement, and clinical outcomes.
• Support implementation planning for digital health platforms and connected care technologies.
• Partner with Clinical, Commercial, and Customer Success teams to understand user challenges and inform future product enhancements.
• Support customer onboarding, implementation activities, product demonstrations, and post-deployment usability evaluations as needed.

Regulatory & Quality Support

• Develop and maintain human factors engineering documentation required for regulatory submissions and Design History Files (DHF).
• Contribute to risk management documentation and usability evidence required for regulatory clearance and approvals.
• Ensure compliance with applicable regulatory requirements and international standards governing medical device usability and human factors engineering.
• Support audits, quality management system activities, and regulatory submissions as required.

Qualifications:

• Bachelor’s or Master’s degree in Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Systems Design Engineering, Cognitive Psychology, Human-Computer Interaction, Ergonomics, or a related discipline.
• 3+ years of experience applying human factors engineering or usability engineering principles within healthcare, medical devices, digital health, software-as-a-medical-device (SaMD), or other regulated industries.
• Strong understanding of human-centered design methodologies, user research techniques, and usability evaluation methods.
• Experience planning and conducting formative and/or summative usability studies.
• Knowledge of use-related risk analysis methodologies and risk mitigation strategies.
• Experience translating research findings into actionable product and design recommendations.
• Excellent analytical, organizational, documentation, and communication skills.
• Strong collaboration skills with the ability to work effectively across multidisciplinary teams.

Preferred

• Experience with connected medical devices, wearable technologies, remote patient monitoring systems, or digital therapeutics.
• Familiarity with healthcare environments, clinical workflows, and patient engagement programs.
• Knowledge of software user interface evaluation and user experience design principles.
• Experience supporting regulatory submissions for medical devices or digital health products.
• Experience conducting research involving healthcare professionals and patient populations.
• Experience working within ISO 13485 quality management environments.

Working knowledge of:

• IEC 62366-1 – Application of Usability Engineering to Medical Devices
• ISO 14971 – Medical Device Risk Management
• ANSI/AAMI HE75 – Human Factors Engineering Design Guidance
• FDA Human Factors and Usability Engineering Guidance
• Health Canada Human Factors Expectations for Medical Devices
• ISO 13485 – Quality Management Systems (preferred)