Lead Human Factors Engineer (Medical Devices) — Remote

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 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.