Human Factors Engineer

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.

Position Summary:

The Human Factors Engineer 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.

Requirements

• Bachelor’s or M.S. degree in engineering, science or technical related field.
• 3+ years of experience in a human factors engineering position in medical device or other regulated industry.
• 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.
• 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.
• Knowledge of the medical device development process from needs assessment through product life cycle maintenance.
• Travel Requirement: Approximately 50-75%. 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

• Lead human factors activities for assigned projects, providing technical expertise and project coordination across cross-functional teams
• Contribute to establishing 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
• 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
• Collaborate with senior team members on technical approach, regulatory compliance, and HFE methodologies
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees