Human Factors Design Manager

HISTOSONICS INC

5h•Remote

About The Position

HistoSonics is a medical device company, founded in 2009, that has developed a non-invasive, sonic beam therapy platform that uses histotripsy, which is capable of destroying targeted liver tumors. Our mission and passion are to advance the novel science of histotripsy and its powerful benefits, bringing meaningful and transformational change to physicians and their patients. The Human Factors User Centered Design Manager proactively leads the planning, coordination, and execution of human factors, usability, and UI/UX design activities within medical device development projects across the HistoSonics portfolio. This role is responsible for conducting human factors engineering and user-centered design activities as well as developing talent within the organization. This role will lead a growing team that includes experienced HFE practitioners and new hires.

Requirements

Bachelor’s or M.S. degree in engineering, science or technical related field.
7+ years of experience in a human factors engineering position in medical device or other regulated industry.
2+ years of management experience with a demonstrated track record of success.
Experience working in matrixed organizations and cross-site/global teams.
Experience leading user-centered design activities throughout the product lifecycle, including activity scoping, ethnographic research, stakeholder needs identification, workflow design, task analysis, requirements development, user interface design and documentation, use error analysis, and formative and summative usability testing.
A working knowledge of Human Factors/Usability Engineering regulatory standards such as FDA guidance, ISO 14971, IEC 62366, and IEC 60601, as well as related documentation practices
Extensive knowledge of the medical device development process from needs assessment through product life cycle maintenance.
Travel Requirement: Approximately 50%. This is a U.S.-based role that will involve travel to HistoSonics offices, customer sites, clinical study sites, and/or usability testing sites. There may be some activity outside of the United States.

Responsibilities

Provide strategic direction on human factors activities to program and project managers
Leverages expertise of senior team members to establish HFE best practices, regulatory compliance strategies, and technical standards across the portfolio
Partner with Program Directors and Engineering leads to ensure that usability is being considered throughout the product development process across the portfolio
Build, manage and mentor a team of 3-5 human factors engineers and UI/UX designers
Establish end user testing processes and regular feedback mechanisms for continual product improvement across the portfolio
Lead the execution of human factors activities to support new product development and product improvements
Work with cross-functional teams and clinical consultants to build/inform robust design and risk documentation
Plan and execute formative and summative usability studies for projects across the HistoSonics portfolio
Synthesize insights and identify solutions and usability improvements
Support concept generation and iteration with the cross-functional team
Present findings to cross-functional teams and leadership
Facilitate effective collaboration across cross-functional teams
Communicate with internal and external stakeholders to provide updates on human factors activities

Benefits

We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more.
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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