Sr. Software Manager, Indications

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Full Time Professional Plymouth, MN, US

Salary Range: $ To $ Annually

Histo Sonics 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, Histo Sonics 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

Histo Sonics 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.

• 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.

• 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.

• 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.

• 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…