{"id":1617463,"url":"https://alion.io/job/histosonics-principal-human-factors-engineer","title":"Principal Human Factors Engineer","company":{"id":1945754,"name":"HistoSonics","domain":"histosonics.com","url":"https://alion.io/company/histosonics","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"lead","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Plymouth, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":150000,"max":185000,"currency":"USD","period":"year","gross":null,"usd_annual":185000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-08-19T19:30:00Z","employer_posted_date":"2026-08-19","last_verified_at":"2026-10-21T05:40:43Z","board_verified":true,"closed_at":null,"days_open":62,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":62},"description":"HistoSonics is a commercial-stage medtech company advancing the Edison® System, a novel non-invasive sonic beam therapy based on histotripsy. Since receiving FDA De Novo grant for the non-invasive destruction of liver tumors in 2023, the company has progressed beyond initial market entry into commercial expansion, reimbursement momentum, and ongoing clinical and pipeline development. In addition to its current liver tumor indication, HistoSonics is pursuing future indications across multiple applications including kidney, pancreas, prostate, neuro, women’s health, and other significant underserved human health areas, to realize the broader potential histotripsy across multiple disease states and medical specialties.\nWe offer an exciting work culture where cutting-edge science meets real-world application, and each team member’s contribution is important to our success in ensuring our physicians and their patients get what they need most.\nLocation: Plymouth, MN\nPosition Summary (Why this role matters): \nThe Principal Human Factors Engineer (HFE) is an expert-level technical leader responsible for human factors strategy and execution. Working with a high degree of autonomy, they lead critical pre- and post-market workstreams and influence physical and digital user interface design. They strengthen Human Factors processes, mentor HFEs, and partner with cross-functional leaders to advance an inclusive, highly collaborative culture.\nKey Responsibilities (What you’ll do):\nLead human factors strategy and execution across a portfolio of projects and domains, from early design definition and feasibility through launch and post-market monitoring.\nTypical activities on an assigned workstream include:Partner with cross-functional teams and clinical partners to build a deep understanding of users, use environments, clinical workflows, and our product.\nDevelop targeted analyses and use-related risk assessments that inform the design of systems, accessories, and labeling.\nSupport concept generation and iterative design of our user interfaces with cross-functional partners.\nPlan, execute, and document formative and summative usability studies in accordance with applicable regulatory expectations and internal procedures.\nSynthesize insights and identify solutions and usability improvements.\nPresent findings to cross-functional teams and leadership.\nAuthor controlled Human Factors documentation for all phases of the product development process.\nCompile high-quality Human Factors document packages for HistoSonics regulatory submissions and develop responses to questions from regulatory agencies.\n\nLead post-market Human Factors activities, translate field and surveillance insights into actionable recommendations, and drive continuous usability improvements.\nPartner with UX/UI designers and cross-functional teams to apply targeted Human Factors methods that strengthen the digital experience and overall system usability.\nLead continuous improvement of Human Factors processes, methods, templates, and best practices to increase consistency, efficiency, and regulatory readiness.\nPartner with the Director and senior leaders to shape Human Factors and UX/UI Design strategy, including capability development, operating priorities, and long-range planning.\nMentor human factors engineers to support their professional development. \nQualifications and Skills:\nBachelor’s degree in Human Factors Engineering, Biomedical Engineering, Industrial Engineering, Psychology, Product Design, or a related technical discipline.\n10+ years of progressive product development experience, including significant hands-on expertise in the development and commercialization of medical devices.\nExtensive track record of successfully leading human-factors engineering activities for multiple complex workstreams with limited supervision.\nExpert-level competency in tools and processes used for human factors 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.\nDeep understanding and applied knowledge of Human Factors and Risk Management standards and guidance, including ISO 14971, IEC 62366, IEC 60601, ANSI/AAMI HE75, and FDA Human Factors guidance documents.\nExperience interfacing with customers.\nExperience working in matrixed organizations and cross-site/global teams.\nAbility to travel up to 25%, primarily within the United States, to support activities at HistoSonics offices, customer locations, clinical study sites, and usability testing facilities. Occasional international travel may be required.\nBenefits: 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.\nWe 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.\nU.S. Work Authorization & Sponsorship: Employer will not sponsor visas for position.\n#LI-Hybrid","description_format":"text","description_chars":5317,"description_truncated":false,"requirements":{"experience_years_min":10,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Professional development","Vision insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Robotics"],"lifecycle":[{"event":"open","at":"2026-10-01T20:37:18Z"}],"visa":[{"country":"US","licensed_sponsor":true,"evidence":"H-1B filings in 12 months: 4","filings_12m":4,"filings_prev_12m":1,"green_card_filings_12m":0,"median_offered_wage_usd":127500,"route":null,"cap_exempt":false,"checked_at":"2026-10-15T11:24:14+00:00","sources":["US Department of Labor: LCA disclosure data (H-1B, H-1B1, E-3)"],"filings_for_role_12m":0}],"liveness":{"score":33,"band":"fade","label":"Fading","p_open":1,"p_active":0.754,"p_room":0.44,"age_days":62,"expected_fill_days":56,"reasons":["conf:0","win:tail","crowd:"],"computed_at":"2026-10-21T05:46:15Z"},"pay":{"stated_usd_annual":185000,"is_top_pay":true},"html_url":"https://alion.io/job/histosonics-principal-human-factors-engineer","json_url":"https://alion.io/job/histosonics-principal-human-factors-engineer.json","meta":{"generated_at":"2026-10-21T06:38:14Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":9457,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-22T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":1945754},"rest":"https://alion.io/mcp/rest/get_company?id=1945754"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fhistosonics-principal-human-factors-engineer"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fhistosonics-principal-human-factors-engineer"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fhistosonics-principal-human-factors-engineer"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/histosonics-principal-human-factors-engineer\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fhistosonics-principal-human-factors-engineer"}]}