Role: Senior Human Factors and Usability Engineer
Location: Waltham, MA (onsite)
Experience and Skills:
- 6+ years of experience in Human Factors/Usability Engineering
- Expertise in medical device design and development, following standards like ISO 9000, ISO 13485, IEC 62304, IEC 60601, IEC 62366-1, and ISO 14971.
- Experience with class II or III medical devices is preferred.
- Experience in user testing, including formative and summative evaluations for medical devices.
- Ability to work in a fast-paced, collaborative environment and manage multiple tasks.
- Basic knowledge of system design, electrical, mechanical design, and software integration.
- Experience with complex electro-mechanical systems, especially those with fluidic or disposable components, is a bonus.
- Prior experience working with third-party providers and certification labs is a plus.