Medical Device Usability & Human Factors Engineer

Sentec; Lincoln (RI); On-site; USD 90,000 - 110,000; Full time

Benefits offered by this job

Medical

Dental

Vision

HSA

FSA

401K matching

Paid parental leave

Wellness stipend

Tuition reimbursement

Job summary

Sentec, a Swiss-American medical device company, is seeking a Usability & Human Factors Engineer to lead usability activities and support regulatory submissions.

You will collaborate with engineering, clinical and quality teams to identify use-related risks and drive design improvements, ensuring compliance with IEC 62366 and FDA guidance.

The role requires 3+ years in medical device usability, a biomedical engineering background, and occasional travel.

Qualifications

• 3+ years of experience in human factors/usability in the medical device industry.
• Strong analytical skills and the ability to craft concise, precise narratives.
• Ability to understand basic operating principles, design, and the clinical use of complex electromechanical medical devices.
• Willingness to travel up to ~5 trips per year.

Responsibilities

• Plan and execute formative and summative usability studies with protocol development, participant selection, test moderation, data analysis and reporting.
• Develop and maintain usability engineering documentation in accordance with IEC 62366 and FDA guidance.
• Collaborate with cross-functional teams and external partners to identify use-related risks and drive design improvements.
• Support the compilation of submission dossiers for new registrations and changes to existing approvals.
• Support regulatory strategies and verification/validation requirements for new products and changes to ensure compliance.

Skills

Human factors

Analytical skills

Regulatory awareness

Education

Bachelor's degree in Biomedical Engineering or related field

Job description

Sentec, a Swiss-American medical device company, is seeking a Usability & Human Factors Engineer to lead usability activities and support regulatory submissions.

You will collaborate with engineering, clinical and quality teams to identify use-related risks and drive design improvements, ensuring compliance with IEC 62366 and FDA guidance.

The role requires 3+ years in medical device usability, a biomedical engineering background, and occasional travel.