Lead Engineer, Systems Usability, Health
The Lead Engineer, Systems Usability, Health, will provide user focused design guidance, evaluations, and documentation of key system components for a medical wearable technology. This role works closely with customers, product owners and developers to create a platform that is safe and effective for the intended users, uses, and use environments. The candidate will also work in collaboration with other engineering disciplines, regulatory, quality, program management, and partners to deliver products per the product development roadmap and can bring together ideas, information, and has experience with industry standards.
- Responsible for system level usability and design contribution on new product development of emerging technologies.
- Risk analysis documentation: AFMEA, hazard and hazardous situations.
- Creation and maintenance of usability related documentation used for assessment and medical device regulatory compliance.
- Support requirement analysis, use case design, and usability engineering tests.
- Responsible for understanding the system and acting as a usability bridge between the R&D team, product management, system testing, and design teams.
- Ensure that the product meets the needs of internal customers.
- Work directly with users for research and validation testing.
- Evaluate, implement, and administer tools utilized in development validation.
- Provide guidance and support for improvement of engineering methods and practices.
- Provide direction as systems representative to cross functional programs with observations from internal and external customer requests and objectives.
- Interact with customers in various user environments, clearly conveying design goals and recording feedback.
- 7+ years product development experience with minimum 2 years of usability experience within product development in a regulated industry.
- Experience in Human Factors and/or Usability Engineering Process.
- Strong knowledge of regulatory landscape for medical technologies, devices, software, and design principles within and outside the U.S.
- Strong organizational, documentation, and interpersonal skills as well as a willingness to work within a team-oriented environment.
- Experience in creating qualitative and quantitative usability tests. Excellent observation skills for analyzing simulated environments, interactions and user verbal and body language.
- Excellent interviewing skills for user evaluations, strong note taking and listening skills, ability to carry a conversation in a meaningful and appropriate direction to focus on critical problems, effective communication skills that can easily convey design intent and evaluation to cross-functional stakeholders.
- Experience with multitasking, task prioritization, and handling multiple projects of varying complexity.
- Ability to brainstorm, conceptualize and creatively approach design problems, focusing on critical functions, forms, ergonomics, and aesthetics.
- Experience in rapid-prototyping, user interface design, and tools for generating user interface demonstrations.
- Proven experience working under short timelines and delivery dates.
- Familiar in how OR environments are designed, perform and function.
- Experience working with spatial computing, augmented reality, or virtual reality a plus.
- Experience working in wearable and/or mobile computing a plus.
BS in Mechanical/Biomedical Engineering or other related field; MS preferred
All your information will be kept confidential according to Equal Employment Opportunities guidelines.