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. We 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. Location: Plymouth, MN Position Summary: HistoSonics is expanding the power of histotripsy into new indications across the body. The Sr. Software Manager will own the regulatory compliance pathway for software and build the software engineering capability that takes new indications from first-in-human through commercialization. This role will lead compliance and documentation effort: assessing prototype software against IEC 62304, creating Software Development Plans, software risk management file, and DHF deliverables. As a key strategic partner to cross-functional teams, the Sr. Manager helps advance targeted clinical applications and supports successful product launches across multiple anatomical areas, including but not limited to neurological, abdominal, and women’s health indications. This position is currently an individual contributor role with the opportunity to build and lead a software team as the organization grows. Key Responsibilities: IEC 62304 Compliance and Documentation - Assess software against IEC 62304 requirements; define software safety classification and gap analysis. - Author and own the Software Development Plan (SDP), establishing development methodology, configuration management, version control, review, and release processes. - Create and maintain the Software Requirements Specification, Software Architecture Description, and software-level DFMEA in accordance with design controls. - Develop and maintain the requirements-to-implementation traceability matrix across the full software lifecycle. - Partner with the regulatory team to ensure software documentation meets submission standards across jurisdictions. Risk, Test, and Verification Management - Own software risk management activities per ISO 14971 and IEC 62304, including software hazard analysis, DFMEA, and risk control documentation. - Define and maintain the Software Verification and Validation Plan; establish traceability between requirements, test protocols, and objective evidence. - Oversee the writing, review, and execution of software test protocols across unit, integration, and system levels. - Manage defect tracking, regression testing, and software release qualification processes. - Interface with the safety and human factors team to ensure use-related software risks are captured and mitigated. Project Management - Own the software workstream plan, milestones, and resource tracking relative to the overall Neuro software program schedule. - Proactively identify risks and dependencies in the software timeline and communicate status to program leadership. - Manage external software contractors or vendors where applicable, ensuring DHF-compliant deliverables. Team Building and Technical Leadership - Define the staffing model for the Neuro software team; participate in hiring and onboarding of software engineers and test engineers. - Establish software engineering culture and processes that scale as the program grows. - Mentor software engineers and provide technical direction on architecture, implementation, and compliance practices. - Collaborate with the therapy physics team to translate algorithm and system performance requirements into software specifications. - Define appropriate technology stacks for treatment planning and therapy delivery components. Qualifications and Skills: Required - Bachelor's or Master's degree in software engineering, computer science, electrical engineering, or a related field. - 10 or more years of software development experience, with at least 5 years in regulated medical devices. - Demonstrated hands-on experience authoring IEC 62304 compliance documentation including SDP, SRS, architecture description, DFMEA, and trace matrix. - Direct experience with software risk management per ISO 14971, including software hazard analysis and risk control implementation. - Proven experience leading software verification and validation activities, including protocol writing, test execution, and defect management. - Highly familiar with integrating AI tools into DevOps, Git and Relyence (or similar). - Project management experience: tracking milestones, managing dependencies, and communicating status in a fast-moving development environment. - Experience leading or mentoring a software team in a medical device or other regulated environment. - Strong written communication skills and demonstrated ability to produce regulatory-quality documentation. Preferred - Experience building a software team and compliance process from early-stage or prototype in a Class II or Class III medical device context. - Background in capital equipment, surgical, or interventional device software, particularly systems involving real-time hardware control. - Experience with Python, C, or C++ in a medical device context; familiarity with real-time or embedded software architectures. 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. U.S. Work Authorization & Sponsorship: Employer will not sponsor visas for position. #LI-Onsite