{"id":1617452,"url":"https://alion.io/job/histosonics-principal-software-engineer-new-indications","title":"Principal Software Engineer, New Indications","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":"Backend","role_family":"Backend","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":175000,"currency":"USD","period":"year","gross":null,"usd_annual":175000},"salary_estimate":null,"experience_years_min":10,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"C++","optional":false},{"name":"Configuration Management","optional":false},{"name":"Design Controls","optional":false},{"name":"Design History File","optional":false},{"name":"EU MDR","optional":false},{"name":"FMEA","optional":false},{"name":"Git","optional":false},{"name":"IEC 62304","optional":false},{"name":"ISO 14971","optional":false},{"name":"Python","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-09-21T22:04:00Z","employer_posted_date":"2026-09-21","last_verified_at":"2026-10-27T04:01:24Z","board_verified":true,"closed_at":null,"days_open":35,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":35},"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):\nHistoSonics is expanding the power of histotripsy into new indications across the body. The Principal Software Engineer will serve as the technical leader for software development and regulatory compliance across emerging clinical applications. This role will own the software compliance strategy and lead the development of software systems that take new indications from first-in-human studies through commercialization. This will include assessing prototype software against IEC 62304, establishing compliant development plans, author, and overseeing key software lifecycle documentation.\nPosition Summary (Why this role matters):\nAs a key strategic partner to cross-functional teams, the Principal Software Engineer will help advance targeted clinical applications and support successful product launches across multiple anatomical areas, including but not limited to neurological, abdominal, and women’s health indications. This is a highly influential individual contributor role with significant impact on technology strategy, software quality, and product development execution.\nKey Responsibilities (What you’ll do):\nIEC 62304 Compliance and Documentation\nAssess software against IEC 62304 requirements; define software safety classifications and perform gap analyses. \nAuthor and own the Software Development Plan (SDP), establishing development methodology, configuration management, version control, review, and release processes. \nCreate and maintain the Software Requirements Specification (SRS), Software Architecture Description (SAD), and software-level DFMEA in accordance with design controls. \nDevelop and maintain requirements-to-implementation traceability across the software lifecycle. \nPartner with Regulatory Affairs and Quality teams to ensure software documentation meets global submission requirements. \nServe as the subject matter expert for software lifecycle compliance and design control activities. \nRisk, Test, and Verification Leadership\nOwn software risk management activities per ISO 14971 and IEC 62304, including hazard analysis, DFMEA, and risk control implementation. \nDefine and maintain Software Verification and Validation Plans. \nEstablish traceability between requirements, test protocols, and objective evidence. \nLead the review of software test strategies across unit, integration, and system-level verification activities. \nGuide defect management, regression testing, and software release qualification processes. \nCollaborate with Safety and Human Factors teams to ensure use-related software risks are identified and mitigated. \nTechnical Leadership and Software Architecture\nDefine software architecture and technical roadmaps supporting future indications and product evolution. \nLead critical technical decisions regarding software design, scalability, maintainability, and cybersecurity. \nCollaborate with Therapy Physics, Systems Engineering, Clinical, and Product Development teams to translate clinical and system requirements into software specifications. \nDefine appropriate technology stacks and development frameworks for treatment planning and therapy delivery software. \nEvaluate new technologies, tools, and development methodologies to improve product quality and team effectiveness. \nProvide technical mentorship and guidance to software engineers and cross-functional stakeholders. \nProject and Program Leadership\nOwn software project plans, technical milestones, and deliverables aligned with overall program objectives. \nIdentify technical risks, dependencies, and mitigation strategies. \nCoordinate activities with external software vendors and development partners, ensuring design control and DHF-compliant outputs. \nCommunicate technical progress, risks, and recommendations to program leadership and executive stakeholders. \nQualifications and Skills:\nRequired\nBachelor’s degree in Software Engineering, Computer Science, Electrical Engineering, or a related field. \n10+ years of software development experience, including at least 5 years developing software for regulated medical devices. \nDeep expertise in IEC 62304 and software development lifecycle processes for medical devices. \nDemonstrated hands-on experience authoring software compliance documentation, including SDP, SRS, software architecture descriptions, DFMEA, traceability matrices, and verification documentation. \nDirect experience with software risk management per ISO 14971. \nProven experience leading software verification and validation activities across complex systems. \nStrong software architecture and system design expertise. \nExperience integrating AI tools into DevOps, Git, and Relyence (or similar). \nProject leadership experience managing technical deliverables in complex, cross-functional environments. \nExcellent written and verbal communication skills with the ability to produce regulatory-quality documentation and influence technical decisions across the organization. \nPreferred\nExperience building medical device software processes from early-stage development through commercialization. \nBackground in capital equipment, surgical, interventional, or image-guided therapy systems. \nExperience developing software in Python, C, and/or C++ within a regulated environment. \nFamiliarity with real-time and embedded software architectures. \nExperience supporting FDA, EU MDR, and other global regulatory submissions for software-enabled medical devices. \nDemonstrated success serving as a technical lead, architect, or principal engineer on complex multidisciplinary product development programs. \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":7130,"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":["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":74,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.822,"p_room":0.9,"age_days":34,"expected_fill_days":56,"reasons":["conf:0","win:mid"],"computed_at":"2026-10-26T05:57:25Z"},"pay":{"stated_usd_annual":175000,"is_top_pay":false},"html_url":"https://alion.io/job/histosonics-principal-software-engineer-new-indications","json_url":"https://alion.io/job/histosonics-principal-software-engineer-new-indications.json","meta":{"generated_at":"2026-10-27T05:23:13Z","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":5184,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-28T00:00:00Z"}},"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-software-engineer-new-indications"},{"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-software-engineer-new-indications"},{"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-software-engineer-new-indications"},{"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-software-engineer-new-indications\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fhistosonics-principal-software-engineer-new-indications"}]}