Sr. Interaction Design Human Factors Engineer

Company Overview
Outset is a pioneering medical technology company focused on reducing the cost and complexity of dialysis. The company’s Tablo® system is the consumer product version of what today is a terribly complex and prohibitively cumbersome machine for patients to use themselves. We combined consumer product simplicity, wireless data transmission and real-time integrated water purification to enable dialysis anytime, in any setting, managed by anyone. Outset Medical is a privately held company backed by a top-tier syndicate of investors, including Fidelity, T. Rowe Price, Perceptive Advisors, The Partner Fund and Warburg Pincus.

Tablo is a new FDA approved hemodialysis technology in a market that has had little innovation in over a decade. Designed to dramatically improve the care experience for patients and the cost-efficiency for providers and payers, Tablo is aimed at enabling service model innovation in a space that has not fundamentally changed since the 1980s. The company is in the early stages of full commercial launch in US dialysis clinics and hospitals, with a clinical trial underway to expand FDA clearance to include the use of the device at home.

Position Overview
Outset is looking for an energetic, creative, and analytical human factors or interaction design engineer to ensure a superior and streamlined user experience while interacting with Tablo. The ideal candidate would be an interaction designer who is capable of conducting analytical user research and testing, or a human factors engineer capable of designing creative and effective experiences.

This individual will work closely with their upstream product management counterparts to represent the market, user, and clinical needs to create and maintain a consistent and measurable roadmap for Outset. The usability/interaction engineer shall define the “how and who” of the product pipeline Together with product management and clinical development, the upstream usability/interaction engineer will work closely with engineering to ensure Outset products provide positive patient outcomes and a user experience that results in an empowered patient and satisfied clinical staff.

The usability/interaction engineer will be responsible for conducting user research, designing and optimizing the workflow, analyzing and characterizing use-related risks, and conducting formative and summative usability testing of products prior to launch. This individual also works closely with the regulatory group to create the usability engineering documentation required for submission to medical device regulatory agencies.

Essential Job Functions

• Collect and synthesize detailed information on how users interact with Outset Medical’s products through various techniques including interviews, simulations, direct observations, task analyses, and persona development
• Develop detailed user needs, and translate these needs into testable user-interface requirements.
• Contribute to user interface designs by providing and negotiating design recommendations to mitigate use errors and improve usability
• Ensure all user-interface design requirements are met as part of the product development process
• Reinforce a human centered design approach across the organization
• Design, execute, and report on usability (human factors) tests at various stages of product development from early prototypes all the way through formal FDA mandated validation testing. Write and execute usability test protocols. Analyze test data and write test reports. Develop validation strategies for projects involving updates to existing products.
• Assist the risk management team in analyzing complaints from on-market products, updating usability risk assessment and escalating usability-related issues as necessary
• Manage usability engineering activities within development projects and provide schedules and status to technical product managers and engineering project managers.
• Lead or support the development of usability engineering processes at Outset, including the creation and maintenance of department operating procedures, test plan templates, GUI design guidance etc.
• Prepare and review documentation for submission to regulatory agencies and notified bodies. Answer questions and provide additional justification and rationale to any questions received.
• Keep abreast of regulations and best practices for medical device human factors (e.g. IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability
• Engineering to Medical Devices) and advise management regarding potential improvements to internal processes and regulatory issues related to usability engineering.
• Ensure adherence to Company Quality policy and procedures
• Perform other duties as assigned

Requirements/Qualifications:

• BS in Human Factors Engineering, Computer Science with human-computer interface (HCI) emphasis, Human Centered Design, Interaction Design, or related field. MS strongly preferred.
• Minimum 5 years’ Human Factors/Usability Engineering/Interaction Design experience in hardware product development industry.
• Experience in medical device, or similar regulated industry, a significant plus, including AAMI training in “Human Factors for Medical Devices”
• Ability to lead usability engineering activities (i.e. conducting task analyses, establishing usability requirements, creating usability risk analyses, test protocols, and test reports) for a software-controlled electro-mechanical medical device
• Ability to analyze and synthesize large quantities of information into usable communications
• Appreciation and intuitive understanding of how design elements (hierarchy of size, color, spacing, density, etc) combine aesthetically and impact interface usability desired
• Excellent interpersonal, social, negotiation, and decision making skills to build effective relationships across a wide variety of stakeholders
• Excellent communication skills (both written and verbal in English) and able to present ideas clearly in a public setting
• Ability to apply user-centered design and usability engineering principles to product research, development, and design including ability to create prototypes and development plans for interaction design and formative testing
• Strong team player who can incorporate input from others and can generate consensus through inclusion
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment
• Good organizational skills and ability to meet tight deadlines in an environment of competing priorities.
• Ability to routinely work on multiple tasks with multiple people while effectively prioritizing.
• Ability to travel up to 30% time (US)

You are part of an organization that attracts and hires the best talent on the planet! You will be working with a great team of dedicated, friendly and collaborative individuals, developing novel and game changing product(s). We are dedicated to the development and growth of our colleagues.