HistoSonics, Inc. · 2 weeks ago
Human Factors Design Manager
United States
Full-time
Remote
Senior Level
$145K/yr - $170K/yr
7+ years expHistoSonics, Inc. is a medical device company focused on advancing the science of histotripsy for treating liver tumors. They are seeking a Human Factors Design Manager to lead user-centered design activities, manage a team of engineers and designers, and ensure usability is integrated throughout the product development process.
Health CareMedicalMedical Device
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
Qualification
Required
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
Benefits
Health, dental, and vision insurance
Life
Short-term and long-term disability insurance
401(k)
Paid time off
And more
Company
HistoSonics, Inc.
HistoSonics is a growth phase company developing a non-invasive sonic beam therapy platform and procedure using the science of histotripsy.
201-500 employees
H1B Sponsorship
HistoSonics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
Funding
Current Stage
Late StageTotal Funding
$578.79MKey Investors
Alpha Wave VenturesSignature BankJohnson & Johnson Innovation
2025-10-16Private Equity· $250M
2025-08-07Private Equity
2025-08-07Acquired
Leadership Team
Mike Blue
President and CEO
Thomas Davison
Co-Founder - Advisor
Recent News
IEEE Spectrum
2026-01-03
2025-12-28
2025-12-24
Company data provided by crunchbase