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

At Sentec, we are passionate about advancing patient care through innovative medical technology. We are seeking a Usability & Human Factors Engineer to play a critical role in ensuring our products are safe, effective, and compliant with global regulations.

In this cross-functional role, you will lead human factors and usability engineering activities while also supporting regulatory submissions and strategy. You will work closely with engineering, clinical, and quality teams to identify and mitigate use-related risks—ultimately helping bring high-impact medical technologies to market.

What You'll Do

• Plan and execute formative and summative usability studies, including protocol development, participant selection, test moderation, data analysis, and reporting in line with applicable regulatory expectations
• Develop and maintain usability engineering documentation, including use specifications, task analyses, use-related risk analyses, and the usability engineering file, in accordance with IEC 62366 and FDA guidance
• Collaborate with cross-functional teams and external partners to identify use-related risks early, and drive design improvements based on study findings
• Support the compilation of submission dossiers for new registrations and changes to existing approvals in close collaboration with internal and external stakeholders
• Support the development of regulatory strategies and verification and validation requirements for new products and product changes to ensure compliance with applicable regulations and standards

Requirements

Qualifications/Education:

• 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 basic 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

Preferred Skills

• In-depth knowledge of the medical device regulatory framework, with specific expertise in FDA requirements and familiarity with EU MDR 2017/745
• Ability to understand, translate and/or speak German is a plus

Benefits

• Meaningful work in a rapidly growing company with opportunity for advancement
• Directly influence the quality of products and make a difference for patients worldwide
• Opportunities for professional and personal growth
• The salary range for this position is $90,000-$110,000 plus bonus, commensurate with experience and credentials

Sentec offers competitive benefits like Medical, Dental, Vision, HSA, FSA, and 401K matching, as well as paid parental leave, a wellness stipend and tuition reimbursement. Sentec emphasizes employee voices and recognizes hard work making it a promising environment for professional growth. Sentec focuses on delivering impactful healthcare products and improving patient care.

By choosing a career at Sentec, you're not just choosing a job - you're embracing the chance to make a real impact, contributing to the development of innovative medical solutions that support the wellbeing of individuals worldwide.

Sentec is a Swiss-American medical device company specializing in respiratory care. Since its founding in 1999, Sentec utilizes a deep-tech approach that is founded on advanced science and avant-garde technologies for respiratory patients across care areas. Sentec provides healthcare professionals worldwide with non-invasive, continuous monitoring and effective therapeutic solutions.