Human Factors Design Eng II - Exempt

As a Contingent Human Factors Design Engineer II, you will contribute to and lead human factors efforts within the User Centered Design functional group, belonging to the Systems Center of Excellence within the Surgical Operating Unit. This position will support programs based out of North Haven, CT, with opportunities to support additional global programs and cross-OU initiatives. The focus of this role will be a technical contributor to support the Hugo robotics platform, new and released product user research, and human factors engineering for new product development.

• 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

Top 3 Technical Skills Required

• 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

Education and Experience 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 (specific experience in medical device development is strongly preferred)
Work Schedule
Will the contractor be working 40 hours a week? Yes, 40 hours.
Location
Onsite in North Haven, CT.
Interview Timeline
ASAP
Product Line
Hugo RAS
Careers that Change Lives
You will join a world-class team of human factors design engineers responsible for further development and enhancement of advanced surgical technologies for open, minimally invasive, and robotic surgical procedures. Impact patient outcomes. Come for a job, stay for a career. In the Surgical Operating Unit, part of the Medical Surgical Portfolio, we believe patients around the world deserve access to quality care and improved outcomes. We strive to be known for outstanding usability and safety, with products that are free from frustration, matched with an approachable user experience, and convey a sense of precision that users can trust.
Responsibilities
Responsibilities may include the following and other duties may be assigned:

• 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 product 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.
• Works with design engineers to establish system design, operating, and training requirements 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.

Technical Specialist Career Stream
An individual contributor with responsibility in our technical functions to advance existing technology or introduce new technology and therapies. Formulates, delivers, and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower-level professionals. The majority of time is spent delivering R&D, systems, or initiatives related to new technologies or therapies –from design to implementation - while adhering to policies, using specialized knowledge and skills.
Differentiating Factors

• Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects/assignments.
• Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones. May have some involvement in cross-functional assignments.
• Innovation and Complexity: Problems and issues faced are general, and may require understanding of a broader set of issues or other job areas but typically are not complex. Makes adjustments or recommends enhancements in systems and processes to solve problems or improve the effectiveness of the job area.
• Communication and Influence: Communicates primarily and frequently with internal contacts. External interactions are less complex or problem-solving in nature. Contacts others to share information, status, needs, and issues to inform, gain input, and support decision-making.
• Leadership and Talent Management: May provide guidance and assistance to entry-level professionals and/or employees in the Support Career Stream.

Required Knowledge and Experience
Requires practical knowledge and demonstrated competence within the 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 a minimum of 2 years of relevant experience, or an advanced degree with 0 years of experience.