Human Factors Engineer

AmRest Holdings SE; Wrocław; Hybrid; PLN 180,000 - 280,000; Full time

Job summary

S3 Connected Health is seeking a seasoned Human Factors Engineer to lead usability activities for medical device and digital health programs. You will define HF inputs, plan formative and summative studies, and ensure alignment with IEC 62366-1, ISO 14971, MDR, and FDA requirements.

We value experience with SaMD, hardware/software ecosystems, and collaboration across engineering, regulatory, quality, and product teams.

Qualifications

• Experience applying Human Factors Engineering in regulated medical device environments.
• Knowledge of IEC 62366-1 and FDA Human Factors guidance.
• Experience conducting formative and summative usability studies.
• Experience with use-related risk analysis and ISO 14971 integration.
• Experience working on physical medical devices and connected products.
• Familiarity with SaMD and connected medical device ecosystems.
• Ability to work with engineering, regulatory, quality, and product teams.

Responsibilities

• Lead Human Factors and Usability Engineering activities for medical device and digital health programs
• Plan and execute usability engineering activities per IEC 62366-1, FDA HF guidance, ISO 14971, MDR, and FDA requirements
• Develop and maintain Human Factors deliverables including use specifications, task analyses, URRA, study plans, and HF reports
• Define HF design inputs for physical devices and software
• Work with multidisciplinary teams to translate HF findings into product requirements and design decisions
• Support regulatory submissions in the US and international markets
• Develop and improve internal HF Engineering processes, templates, and best practices within our QMS
• Mentor, coach, and share knowledge across the organization
• Participate in client workshops, design reviews, and product strategy discussions

Skills

Human Factors

Regulated devices

IEC 62366-1

FDA HF guidance

Formative studies

Summative studies

URRA

Risk management

Cross-functional

SaMD familiarity

Job description

S3 Connected Health is a leading digital health company headquartered in Dublin, Ireland. We are a team of over 250 clinicians, behavioral scientists, and technologists dedicated to transforming healthcare through innovative digital solutions. We create state-of-the-art platforms for remote patient monitoring, medication adherence, and patient engagement that empower millions to improve their health and quality of life.

What you'll do

• Lead Human Factors and Usability Engineering activities for medical device and digital health programs
• Plan and execute usability engineering activities in accordance with IEC 62366-1, FDA Human Factors guidance, ISO 14971, MDR, and FDA requirements
• Develop and maintain Human Factors deliverables including use specifications, task analyses, use-related risk analyses (URRA), formative and summative study plans, and Human Factors reports
• Define Human Factors design inputs for both physical devices and software solutions
• Work with multidisciplinary teams to ensure Human Factors findings are translated into product requirements and design decisions
• Support regulatory submissions in the US and international markets
• Develop and improve internal Human Factors Engineering processes, procedures, templates, and best practices within our Quality Management System
• Contribute to capability development across the organization through mentoring, coaching, and knowledge sharing
• Participate in client workshops, design reviews, and product strategy discussions

What we're looking for:

• Experience applying Human Factors Engineering or Usability Engineering in regulated medical device environments
• Strong understanding of IEC 62366-1 and FDA Human Factors guidance
• Experience conducting formative and summative usability studies
• Experience with use-related risk analysis and integration with risk management processes (ISO 14971)
• Experience working on physical medical devices, not only digital products
• Experience working on connected products combining hardware and software
• Familiarity with Software as a Medical Device (SaMD) and/or connected medical device ecosystems
• Ability to work effectively with engineering, regulatory, quality, and product teams
• Strong communication and stakeholder management skills

Nice to have:

• Experience supporting FDA submissions, De Novo or 510(k) programs
• Experience with home-use medical devices
• Experience creating Instructions for Use (IFU), training materials, or labeling
• Experience with accessibility standards and inclusive design
• Background in behavioral science-informed product development
• Experience improving or maintaining QMS processes related to Human Factors Engineering
• Work on products that have a real impact on patients' lives
• Collaborate with multidisciplinary teams spanning product design, software, hardware, systems engineering, quality, and regulatory affairs
• Contribute to innovative connected medical device and digital health programs across global markets
• Be part of an organization with deep expertise in regulated healthcare technology and a strong track record of bringing complex products to market
• Enjoy a flexible working model with remote, hybrid and office-based collaboration options

We reserve the right to contact only the chosen candidates.