Scalence L.L.C. · 1 week ago
Human Factors Design Eng II
North Haven, CT
Full-time
Onsite
Entry, Mid Level
$45/hr - $50/hr
2+ years expScalence L.L.C. is a company focused on advanced surgical technologies, seeking a Human Factors Design Engineer II to contribute to their User Centered Design functional group. The role involves leading human factors efforts, supporting the Hugo robotics platform, and conducting usability studies to enhance product user experience.
Information Technology & Services
Responsibilities
Designing usability studies and driving testing strategies
Moderating usability testing of prototypes with end users and customers
Aiding in data collection and root cause analysis during usability testing
Responsible for Use-related Risk Analysis documentation
Provide technical insight for user interface design, HF processes, and planning for team and business strategy
Perform observation / contextual inquiry for applicable use cases/environments e.g. Surgery
Moderate interviews with end users and customers for the purpose of need finding, use case identification, use condition identification, use error identification, validation of customer and user needs, and determining effectiveness of risk controls
Contribute and maintain human factors program documentation as needed for the Usability Engineering File
Aiding teams with preparation of usability-related documentation for regulatory body submissions
Aid in identifying use-related issues upon post-market launch and provide recommendations of risk control enhancements
Applies human centered principles, methodologies, and technologies to the design of human-machine systems and products
Develops and implements research methodologies and both qualitative and quantitative analysis plans to test and evaluate new concepts and developmental prototypes used in all phases of products development and processes
Designs and executes tests to simulate product use for the purposes of user need investigation, concept exploration/selection/refinement, requirements development, use-related risk identification and formal usability validation with intended users with design engineers to establish system design, operating, and training requirements and to ensure optimized human-machine interfaces and overall user experience
Identifies and analyzes technological problems or risks, performs theoretical human factors investigations, and develops and implements research and analysis plans to inform the design direction of new product development
Qualification
Required
BS in Human Factors or a closely-related field (such as Biomedical Engineering, Industrial Design, Industrial Engineering) with 2+ years' experience
MS or higher with 0 years' experience
Planning, conducting, and documenting usability testing in a medical device use context
Planning, scaling, documenting, and executing human factors program activities in accordance with FDA guidance and other relevant international standards (e.g., IEC 62366, IEC 60601, ISO 14971)
Use-related Risk analysis
Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 2 years of relevant experience, or advanced degree with 0 years of experience
Preferred
Specific experience in medical device development is strongly preferred
Company
Scalence L.L.C.
In today’s dynamic and competitive market, success hinges on mastering three key areas: Data Intelligence, Business Resilience, and Digital Experience.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase