Medical Device Usability & Human Factors Engineer

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

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

HSA/FSA

401K matching

Parental leave

Wellness stipend

Tuition reimbursement

Job summary

Sentec, a Swiss-American medical device company, focuses on respiratory care and patient support. Since its founding in 1999, Sentec employs a deep-tech approach to deliver non-invasive, continuous monitoring and effective therapeutic solutions for respiratory patients worldwide.

The Usability & Human Factors Engineer will lead human factors and usability activities, support regulatory submissions, and work with engineering, clinical, and quality teams to identify use-related risks and drive

Qualifications

• 3+ years of experience in human factors/usability in the medical device industry.
• Bachelor’s degree in biomedical engineering or related scientific or engineering background.
• Strong technical background and competency.
• Ability to understand operating principles, design, and the clinical use of complex electromechanical medical devices.
• Strong analytical skills and the ability to compile scientific/engineering data, and craft concise, precise, and persuasive narratives.
• Ability to travel as needed up to approximately five trips per year.

Responsibilities

• Plan and run formative and summative usability studies per regulatory guidelines.
• Develop and maintain usability documentation (use specifications, task analyses, risk analyses, and the usability file) per IEC 62366/FDA.
• Collaborate with cross-functional teams to identify use-related risks and drive design improvements.
• Support submission dossiers for new registrations and changes with stakeholders.
• Support regulatory strategies and verification/validation requirements for new products.

Skills

Human factors

Usability testing

Regulatory knowledge

Analytical skills

Travel readiness

Education

Bachelor's degree in biomedical engineering or related scientific/engineering background

Job description

Sentec, a Swiss-American medical device company, focuses on respiratory care and patient support. Since its founding in 1999, Sentec employs a deep-tech approach to deliver non-invasive, continuous monitoring and effective therapeutic solutions for respiratory patients worldwide.

The Usability & Human Factors Engineer will lead human factors and usability activities, support regulatory submissions, and work with engineering, clinical, and quality teams to identify use-related risks and drive